Pharmaceutical industry analysis in bangladesh

Obvious medicines will be the products which might be invented by company, who have their own research team focusing on their own laboratories. These products are patented for many years to enjoy the monopoly industry. After years of business the formulation is sold in the market so that others go into mass production.

General medicines are definitely the products that are produced in mass scale. These are generally marketed simply by several companies below different manufacturer, where the formula of this method almost same.

Prices of the products are under this category are competitive. Bangladesh generally concentrates on this category, as labor cost is one of many lowest on the globe.

Growth & Trends:

The expansion potential of pharmaceutical market is tremendous. As downtown population is increasing and individuals are getting knowledgeable, they are now more concerned about healthcare. So the demands of medical products will be rising. In Bangladesh unhygienic conditions and poor health protection plans provide vast range for the pharmaceutical businesses to sell their products.

On the other hand, the constant all-natural disasters offer opportunities to pharmaceutical drug companies to improve its revenue. The market is growing the protection of national Medicine Policy 1982. But following your GATT regulation, changes will be bound to take place. Furthermore, the trend & growth of this sector tends to be confident as the demand of drugs is growing, which have described earlier.

HEALTH-RELATED AND PHARMACEUTICAL DRUG SECTOR: EASILY

Particulars Number/Quantity

Total Area of Bangladesh 147, 570 Sq . Kilometres

Population more than 133. 40 , 000, 000

Primitive Birth Charge (CBR) 19. 00 (per 1000)

Crude Fatality Rate (CDR) 4. 80 (per 1000)

Every Capita Annual rent (CAI) 470 (in US$)

Total National Foreign trade 6, 889. 30 million US$

Total Nationwide Import twelve, 903. 00 million US$

Number of Countries Released (P/ products) 62 em.

Count of Signed up P/Industries 235 nos.

Total Number of P/Industries in operation 154 em.

Total Market Size 697 , 000, 000 US$

Percentage of Production of Local Sectors 96%

Percentage of Import against local industry 4%

Number of drugs produced by community P/C 450 generic products

Quantity of drugs manipulated 117 universal items

Number of medicines decontrolled 333 generic Products

Quantity of drugs mainly demanded 40 generic Things

Quantity of Industries producing raw materials twenty one companies Range of API staying produced forty one Items

Drugs manufactured in generic Term 450 items

Medicines produced in name brand 5, 500 items

Drugs manufactured in strength (number ) almost 8, 000 items

Contribution to the income sector a few. 00 US$

Contribution to the GDP 1 . 25 percentage

Total Career Creation (more than) 80, 000 em.

Volume of Licensed Chemist (Drug seller) 68, 500 nos.

Number of Chemist without Permit 52, 500 nos.

Component Endowment:

In economics a country’s factor endowment is usually realized as how much land, labor, capital and infrastructure that a country or perhaps industry offers and can take advantage of for manufacturing. Industries which has a large endowment of resources tend to be more productive than those using a small

endowment. The development of sound corporations to access and equitably spread these methods, however , is necessary in order for a market to obtain the greatest benefit from the factor endowment. Nevertheless, the new world financial systems inherited desirable endowments just like ideal situation, suitable size of the sector or skillful manpower. In case there is pharmaceutical industries in Bangladesh, they have committed to land to increase their organization widely inside and across the country. Day by day this kind of sector can be making a random physical change to grasp the international marketplace. All the firms in Bangladesh have increased their physical size with huge success. Pharmaceutical companies have also equiped a large number of experienced manpower intended for the enhancement of this sector. A huge amount of individuals have been educated well to successfully run the pharmaceutical drug companies about the country and outside as well. Demand:

Bangladesh is definitely prone to warm diseases, and this leads to an increased demand for pharmaceutical goods. Due to this and the illness and care situations, a stable growth in the pharmaceutical sector is possible. Demand is positively related to all of the changes in throw away income. Let’s assume that income per capita will certainly continue to enhance, it may be predicted that the demand for pharmaceuticals will even continue to rise.

Dhaka is the major contributor, with nearly 35% market share. Chittagong and Sylhet follow with 26% business each. Khulna has a much smaller share of 14%, but it really has an huge growth potential because of the bigger value product sales per chemist.

Dhaka even offers the highest every capita spending on medications. Studies show that people in urban areas usually consume even more pharmaceutical items compared to persons living in countryside areas.

Urbanization is gradually increasing in Bangladesh, as increasing numbers of people transfer from rural areas to reside Dhaka as well as the other cities. Because of the improved frequency in natural catastrophes, people want to live and work in cities other than in villages. This contains a direct influence on the volume of sales in the pharmaceutical businesses. As even more people are residing in

relatively developed areas, the demand pertaining to medicine is usually rising. This provides a great opportunity for the companies to boost their revenue.

Market leads and industry entry strategy

1 . Macro economic environment

The overall macro economic environment is very positive and favorable intended for international organization. Both importance and foreign trade are elevating; import is usually increasing since the country features moved to making sector even more aggressively due to availability of qualified and more affordable labor force. To be able to carry out international business easily, the countrywide information system (NII) has also improved. The government has introduced tolerante policy to draw for the foreign investors, organization and commercial organizations. The country is suffering from slow yet steady development in the Gross Domestic Merchandise (GDP) at 5. 33%. Key symptoms of progressive improvement in the economy are great; Per capita income has increased at US$ 470 (June 2005), literacy rate has increased at 65%, average life span rate has grown at sixty-eight. 2 years, twelve-monthly export expansion is being unfaithful. 39% when import grew only in 13%. Pumpiing rate provides reduced in 5. 1%. Per household expenditure about medicine has grown at much more than US$ 5. 00, which is among then simply lowest in Asian countries, compared to developed countries. But , this indicates good potential for the growth of domestic market. The pharmaceuticals sector is a growth sector as mentioned in the last chapters. Upcoming potential for this kind of sector is additionally bright. The latest export overall performance has drawn the attention from the government. But , the pharmaceutical industry sector is heavily depended on imported raw materials. Rapid growth in the export market has created chance to expand development capacity. The sector can be seen at a glance through the attached sector profile

2 . Availability of marketing services

In Bangladesh, all kinds of advertising market promo services will be availability. There are marketing companies who can consider up assignment of marketing and distribution of goods overall the country. A large pool area of sales force has been developed over the last twenty-two years who are able to take the goods to the front door of the owners through a hundred and twenty, 000 retailed

Pharmacists. To organize a sales and marketing push, expert solutions can be extracted from local supply. Moreover, you will discover marketing and marketing agencies, marketers, indenters and stockiest. Agencies are there to import skill development teaching on product sales, marketing and distribution. There are transact journals, media letters and trade programs specifically for the pharmaceuticals sector. There are a a large number of event organizers who can organize trade festivals, exhibitions and other events.

several. Recommended technique for new traders

Following success stories in the leading firms, several factors have been considered as critical to success and these are comes after:

¢ Quality product through top quality production program

¢ Skilled and trained staff members for product promotion

¢ New and a comprehensive portfolio of products

¢ Progressive promotional methods.

¢ Strong backward linkage support with or perhaps outside the nation ¢ Immediate and cost effective delivery and distribution network with depots ¢ Desirable packing and packaging with detailed specs ¢ Ongoing research and development intended for improvement of goods ¢ Audio operational plan including marketing and financial preparing

In the days to come, the local marketplace will be very competitive. A new organization should be well prepared with all sorts of planning like marketing and promotion, procurement and production, distribution and delivery, sound economical management, ground breaking product development. A great combination of a number of major components may provide success for virtually any new competitor in this sector and these are generally as follows:

(a) Product attributes

154 companies are selling common products, such tablets, capsules, thick syrup (liquid) etc . To attain competitive edge, new entrant will need to emphasis on fresh dosage forms like, Anti-biotic, drugs, inhaler, suppositories, hook free injections, patch injection etc . Herbal products possess a large potential market.

(b) Price

Since the federal government strictly settings price of pharmaceutical goods, a new company should take up ‘shadow or indirect’ costs method.

(c) Trade funnel

Businesses should undertake trade stations that reduce their circulation and other costs. Possibility ought to be explored to get institutional orders. Agreement manufacturing may be one of the alternatives since the revised policy permits it.

(d) Promotion

Since immediate product promo activities are prohibited various other means needs to be applied. Press selling program can be an successful technique for product promotion. Besides, incentives in different forms may be given to the field level sales force, doctors and doctors. Sponsoring several events like workshops, workshops on drugs and health care related issues and funding charitable health care activities can be adopted.

(e) Joint venture preparations

Partnership arrangement with foreign most respected pharmaceutical firms having plant for API possibly contact form USA, Europe-Scandinavian countries, The japanese will be best option for any new entrant.

(f) Buy out and mergers

Recently, many MNCs combined. In Bangladesh, there are heavy factories which can be bought and restarted through infusing clean funds.

Related industrial sectors of pharmaceutical companies:

Pharmaceutical sector itself is known as a potential one out of Bangladesh. Additionally, there are some assisting sectors along with this one in our country:

Advantages, weaknesses, opportunities and hazards:

The strategic research on the pharmaceutical drugs industry of Bangladesh shows the following outcomes: Strengths with the industry are as follows:

¢ 5-7 leading companies are world class

¢ Products acceptable in the global marketplace as ‘Quality Products’ ¢ Wide range

of products

¢ Price are competitive at local and foreign market

¢ Strong company image created by the marketplace leaders parallel to MNCs ¢ Significant pool of efficient and qualified technical manpower at minimum expense ¢ Supportive government policy attracting overseas investors ¢ Do not have to comply with IPR until 2016.

¢ Backward addition support has been created

¢ Significant domestic marketplace with sensible growth

¢ Earliest and one of the largest sector in terms of capital investment Weak points of the market are as follows:

¢ Dependency on imported unprocessed trash or lack of API plant life ¢ Absence of international common quality control and screening laboratory ¢ Absence of bio-equivalence testing and clinical establishments ¢ Insufficient knowledge on TRIPS and trade related matters

¢ Little r and d on new molecule advancement

Opportunities for the Market are the following:

¢ Large possibility of export marketplace expansion coming from 2006 until 2016 ¢ Huge potential to set-up manufacturing plant for API or mass drugs ¢ Liberal government policy intended for the foreign buyers for joint venture pharmaceuticals device ¢ Significant pool of qualified technical personnel may possibly set up making units in other LDCs ¢ Local businesses can offer specialized know-how to LDCs for setting plant life. ¢ Household market is little by little increasing with the increase in GDP ¢ Opportunity for merchandise diversification in herbal and animal health-related. ¢ R and d activities could possibly be initiated with external support ¢ Opportunity to take advantage of compulsory licensing, seite an seite import and bolar procedures

Threats pertaining to the market are as follows:

¢ Cheaper medication from China and India

¢ JOURNEYS may provide tough competition in the local and export market ¢ India offers amended 1970 Patents Behave as favorable as is possible ¢ The sector depends on brought in raw materials any kind of fluctuation in raw materials prices

or price of exchange will have unfavorable affect on competitive prices. ¢ Access of international with large scale investment with strong backward linkage support ¢ Nearby countries supplying products to Bangladesh through unauthorized channel. ¢ Brought in drugs will probably be in the local industry after enactment of revised drug coverage

Cultural Variety:

Human population groups which have been conventionally defined along racial and ethnic categories consist of important subgroups whose special needs and drug answers traditionally have been completely undervalued or ignored. The factors determining population variations in response to medications happen to be complex and interdependent. Environmental factors (e. g., climate, smoking, liquor consumption) may possibly have a profound impact on drug metabolism. Biologic elements such as genetic polymorphisms (naturally occurring different versions in the set ups of genetics, drug metabolic rate enzymes, receptor proteins, and also other proteins linked to drug response or disease progression), grow older, and gender have significant influence and may require the application of alternate drugs or doses in people of different racial and ethnic backgrounds. Genetic research in the past few decades has uncovered significant differences between populations inside the metabolism, scientific effectiveness, and side effect information of in therapy important medications. Yet ethnical differences likewise have been noted to influence a patient’s adherence to, and therefore the success of, drug therapy. For instance , trust and respect pertaining to patients and the health beliefs and methods, as well as sales and marketing communications issues, had been found to influence devotedness to medicine regimens. Patients’ beliefs about the nature of disease, acceptance of side effects, and preferences concerning herbal or perhaps traditional solutions may be influenced by a selection of socio-cultural impacts, including sexuality, socioeconomic course, education, zugezogener status, and religion, all of these must be considered. Additionally , marketing communications barriers may lead to incorrect understanding of diagnostic category and recommendations regarding treatment. Similarly, inadequate health literacy may impact the ability to appreciate and move on health information issues.

Direct-to-Consumer Advertising and marketing

Direct-to-Consumer (DTC) Advertising is a form of marketing in which adverts for pharmaceutical drug products are aimed directly at buyers, in addition to medical companies and payers. The discussion around DTC can be centered on whether direct-to-consumer advertising provides value for consumers, prompts ideal use, and whether this increases diagnosis of otherwise overlooked medical problems. To address developing concerns regarding DTC marketing, PhRMA accepted and produced voluntary guiding principles pertaining to industry to follow along with in developing DTC advertising and marketing. Key elements contain: * Submitting all advertising to the FOOD AND DRUG ADMINISTRATION prior to transmit; * Openness regarding the actual advertised medicine is intended to treat; * Balanced presentation of risks and benefits; and

* Educating care providers about a medicine before calling consumers.

Disease Management and Medicaid Overall health Outcomes Supervision

Price containment of pharmaceutical costs usually involves various initiatives to control drug utilization. These efforts commonly are directed at physician suppliers, pharmacist suppliers, or the pharmaceutic industry. They have included the establishment of drug formularies and before authorization courses. Governmental guidelines has had a significant role in shaping these types of efforts. A new approach to cost hold is disease management. Disease management refers to a system of coordinated healthcare interventions intended for populations with conditions through which patient self-care efforts are significant. The goal of disease management programs is to optimize therapy. Enhancing therapy will need to improve results and decrease overall expenditures connected with a disease.

Disadvantages of Aspect Management

In medical care, component management is the practice of separately managing person cost motorists, such as prescription medications, hospital tickets and doctor visits, rather than considering the fundamental health issues of patients or total blend features within a health care plan. Through component managing, health care plans try to lower overall costs by looking into making changes certain to a expense driver. When ever prescription drugs will be managed being a

separate component, for instance , there is no account given to the consequence of appropriate drug use on the use of various other medical services. Restricting medicine use through formularies or more co repayments might cause lower usage of medicines, nevertheless studies have got found that doing so makes higher costs through elevated hospitalization and also other health problems. Medicine Spending Tendencies

Increased investing in prescription drugs is normally attributed to larger prices intended for existing and new medications. However , increases in spending also are dependant upon the volume of prescription drugs taken by patients, which can be defined as the number of prescriptions plus the number of days for which a given pharmaceutical drug provides remedy. Research supported by the National Pharmaceutical Authorities developed the strategy needed to identify the specific selling price and volume factors accountable for increased medicine spending. This kind of research discovered that improved use of prescription drugs due to better diagnosis of disease, new medical recommendations for treatment, and in some cases, new, more effective drugs may perform a larger position than improves in price in explaining improved spending developments.

Strategy of operating pharmaceutical industry:

The pharmaceutic industry is a world’s greatest industry. Pharmacy industry has seen significant changes in the the past few years that place new requirements on payers, providers and manufacturers. Buyers now demand the same choice and comfort from drug-store industry that they can find in other segment. Bangladeshi Pharmaceutical Sector is ready for high consistent development over the next few years, driven by a multitude of factors. Top Bangladeshi Companies just like Square, Opsonin and Beximco have already founded their presence. The pharmaceutical drug industry is a knowledge powered industry which is heavily dependent upon Research and Development for new products and growth. However , preliminary research (Discovering fresh molecules) can be described as time consuming and expensive process and is as a result, dominated simply by large global multinationals.

Although many pharmaceutical corporations have successfully deployed a plethora of strategies to concentrate on the various consumer types, latest business and customer trends are creating new issues and options for increasing

earnings. In the pharmaceutical and healthcare industries, a fancy web of decision-makers determines the nature of the transaction (prescription) for which direct customer of pharmacy sector (doctor) is responsible. Essentially, the end-user (patient) uses a product and pays the cost. Use of medical representatives pertaining to marketing items to physicians and to apply some influence over other folks in the pecking order of decision makers is a huge time-tested traditions. Typically, salesforce expense includes an estimated 12-15 percent to twenty percent of annual product revenues, the biggest line item on the balance sheet. Despite this other expense the industry is still plagued with a few very serious proper and detailed level issues. From organizational perspective the most prominent performance related issues are enrolled below: a) Increased competition and shortened window of opportunity. b) Low level of customer understanding (Doctors, Suppliers, Wholesalers). c) Poor buyer acquisition, creation and preservation strategies d) Varying buyer perception.

e) The number and the quality of medical staff.

f) High schooling and re-training costs of sales employees.

g) Very high attrition rate from the sales personnel.

h) Busy doctors giving less time for sales calls.

The pharmaceutic industry is definitely characterized by weighty R&D expenses. It is only the best pharmaceutical firms who can spend significant resources for R&D to introduce new releases. As the items are effects of significant R&D expenses incurred by simply these companies, they have their products patented. The patent allows the firms concerned to wield huge pricing power for their new releases. What’s the secret behind these successes? For one, the company are operating in niche preparations (chronic) portions such as psychiatry, cardiovascular, gastroentology and neurology. While most in the top Bangladeshi companies possess focused on antibiotics and anti” infectives (acute), Aristo Pharma focused on healing areas including depression, hypertonie and cancer. The company features the entire product selection and features gained management position in each of these areas. Being a specialised, company closes off Aristo pharma from the sector growth. Among the constants of pharmaceutical firm strategy over the past decade has been increasing scale.

Only by growing larger are businesses able to afford the considerable costs of drug development and distribution. Through this broad way at least two business models are discernable: (i) Super Key Model relating to the search for, and distribution of your small number of prescription drugs from Long-term Therapy Region that attain substantial global sales. The success of this model is determined by achieving large returns from being a mere number of medications in order to spend on the high cost of the medication discovery and development method for a numerous patients. Total revenues are quite dependant on revenue from a small volume of drugs. (ii) Core Version in which a greater number of medicines from Acute Therapy Location are directed at big diversified markets. The main advantage of this model is that its success is usually not dependant on sales of a small number of medicines. Medical reps are rearranged throughout the new companies. Some of the sales representatives are now afraid of burning off their task, due to the changing scenario as well as the possible lay down offs. However, the new, larger, pharmaceutical companies are competing more and more with one another, and, in order to anxiety their products, might adopt a much more aggressive revenue strategy. For instance , sometimes inside the same geographical area you will discover five reps for just one firm, or different representatives for the similar drug in several settings. Due to the new, intense strategy, the aggressiveness of representatives is increasing, considering that the larger pressure exerted by way of a companies might affect their particular stay in the business. Therefore , they have a tendency to have more frequent sessions to encourage doctors to prescribe medications and thus maximize sales. Pharmaceutic marketing can be described as specialized discipline where medical representatives constitute the backbone of entire marketing effort. Pharmaceutical drug companies likewise appoint medical representatives and assign all of them defined areas. Medical representatives meet doctors, chemists and stockiest as per company norms. Medical staff try to effect prescription design of doctors in favor of their particular brands.

Export

There is tremendous potential for the export of medicine from Bangladesh to become a growing, booming organization. The pharmaceutical sector has a large potential market overseas. Drugs manufactured in the country directions high demand

in the international markets while the sector maintains top quality.

Policy takes on important role in boosting any kind of industrial sector and that has happened to the pharmaceutical market of the country. 1982 is recognized as as a landmark in the pharmaceutic industry good Bangladesh when a new Drug Policy was formulated back in. The objective of the policy was to become self-reliant in the pharmaceuticals sector to supply essential prescription drugs to sufferers at an cost-effective cost, to uphold customers interest by giving them powerful and quality drugs. Medication Policy was found extremely successful in achieving nearly all its reported objectives. In fact , Bangladesh was the first as well as the pioneer in formulating this kind of a policy inside the line together with the guidelines for essential prescription drugs as recommended by the Globe Health Organization (WHO).

The Drug Coverage is below review in order to meet the demands of the present time. Based on the Minister, Ministry of Health insurance and Family Well being, Dr . Khandaker Mosharraf Hossain, the draft has already been recommended. To his opinion the reviewed plan will even more facilitate the growth of the pharmaceutical sector. (Source: The Business Bangladesh, March 2004)

Bangladesh is currently almost a self-sufficient in the pharmaceuticals sector as 97% of the nation drug demand is met by simply local producers. With the achievement in the home market place the Bangladesh Pharmaceutical drug Industries are actually attempting to access the foreign market.

Strength and weak points of Bangladeshi P/companies

In general, Bangladeshi pharmaceuticals businesses are now more powerful in terms of top quality product, attractive design, secure packing, regular delivery, and competitive value. Almost every very good company features ISO license and high quality control system run by qualified staff. The leading businesses are maintaining international standards in every spheres of their business activities. Several companies happen to be of universe standard and deserve strong competitiveness in the world market. Main weakness with the local firms is the addiction on the imported raw materials. R and d needs to be advanced further pertaining to long term sustainability.

1 . Product design

Although product design differs from company to company, nevertheless the leading regional and overseas companies have got certain regular on merchandise designing that may be acceptable to world marketplace. They use top quality design of provides, strips, container cover etc .

2 Top quality

Leading 25 companies are producing products of intercontinental standard and all manufacturers comply with Gross Developing Practice (GMP).

3. Cost

Considering that the local government strictly controls price of pharmaceutical products, there is also a very negligible price difference. The maximum retail-selling price of the product will probably be just dual the price of API plus useful tax at15% VAT. However the price of recycleables is competitive which is set based on international market situation.

4. Conditions

Stipulations of product sales are nearly same for each company, because the profit perimeter is almost same for every item. Usual low cost for the traders/retailers’ level is 12-15% for neighborhood Formulations and 10-12% price cut for imported Formulations. A lot of companies provide special price cut to the investors that amounts from 2 . 5% to 7. 5%. Provision of credit sales is not really usual practice.

5. Delivery

Most companies deliver products to the suppliers and dealers by their personal transport set up as impartial third party distribution channel will not exist.

6th. Back-up solutions

Back-up services are available at retailers’ level. Ended unsold products are returned at a specific percentage. Reduction and problems are also compensated depending on the volume of medicine.

six. Promotion

Market and sales advertising activities will be carried out by field level sales force. Every firm has its own sales at community and foreign level. Essential transport establishments are given to the sales force during a call to visit doctors, health care centers, hospitals and private practitioners. Just product literary works, pad, diary, gifts, and so forth are used during sales calls. Adequate promotional materials are distributed to the training Doctors for regular make use of. According to the community laws, ad on items or brands is prohibited through any kind of media. Product advertisement can be published inside the medical journals provided there exists prior agreement from the concerned authority.

Craze of foreign trade

Export of local pharmaceutic products has experienced positive growth over the last one 10 years. In fact , this has been a great accomplishment for the sector overall, which has been sooner or later possible because of the government liberalization policy together with a favorable and conducive Nationwide Drug Policy in 1982. Initial export of pharmaceutical items was made 39 years ago and the quantity was very insignificant. Expansion in the amount of export of pharmaceuticals was very slow until 1990. Following 1990, the volume of export of pharmaceutical drugs had started out growing and over the years, the volume has increased gradually. Increasing pattern in the export of drugs has continuing till this season. During the five months (July2003-April 2004), Bangladesh made an export of US$ almost 8. 66 , 000, 000 and predicted export for the year will be US$ 15. 39 , 000, 000. At present, Bangladeshi pharmaceutical firms export to more than 50 countries which include Bhutan, Myanmar, Cambodia, Hk, India, Dalam negri, Japan, Korea, Maldives, Nepal, Pakistan, Philippines, Singapore, Sri Lanka, Thailand, Vietnam, Brazil, Colombia, Egypt, Ethiopia, Finland, Portugal, Ghana, Portugal, Iran, Geordan, Kenya, Korea Republic, South america, Netherlands, Norway, Papua New Gini, Soudi Arabia, Sudan, Yemen, Djibuti, Senegal, Indonesia, USA, Oman, Russia, Ukraine, Austria, Australia, Belgium, Malawi, Malaysia, Middle East and so forth Several companies include opened all their overseas part to promote foreign trade market.

Neighborhood pharmaceutical corporations exporting items are particularly, Beximco, Sq ., Jayson, EXTREME, Renata, Gonoshastha, Novartis, Eskayef, Essential Medicines Company Limited, Global Capsules, Navana, Maxfair, Millat, Skylab, Aristopharma, UniMed and Unihealth, Modern, Beximco Infusion, Opsonin, Drug Worldwide, Medimet, ACI, General, Nipa and Aventis. Major development in foreign trade of pharmaceuticals has been attained in the taking part countries those people who are going to go to the Asia HealthCare 2005. Countries which have been importing items from Bangladesh are particularly, Vietnam, Israel, Thailand, Singapore, Sri Lanka, Malaysia, Indonesia, Cambodia, China, Nepal, India. These kinds of countries import pharmaceutical items from Bangladesh on regular basis, even though the quantity of import is not so significant.

Foreign trade impediments

Even though the government offers formulated beneficial policies, the exporters of pharmaceutical still face this constraints and impediments: ¢ Allocation of inadequate bills for functioning foreign product sales office ¢ Registration in the importing Countries

¢ Hold off in issuance of the FSC Issue of “Free Sale Certificate by Regulatory Specialist ¢ Deficiency of incentive pertaining to Export

¢ Customs hassle for shipment of Samples

¢ Absence of Data Base on Importers and Exporters.

¢ Difficulties in finding reliable Distributors/ Agents

¢ Irrational tariff imp?t

¢ Lack of Information on Importing Countries on subject relating federal government formalities, Sign up requirements.

Existing export expansion plans

Some 27 local pharmaceuticals companies are on a regular basis exporting by Bangladesh and all of them include annual export development plans. New companies are preparing to enter into foreign trade market and developing their particular export programs. Individual businesses initiate their particular export advertising activities. Until now, the government or perhaps the trade advertising office’s contribution to endorsing export industry was negligible. Individual corporations

encourage their item through playing the international Trade fairs and Displays of pharmaceutical products, spread product materials and trip to the potential foreign potential buyers and providers. The existing exporters apply the subsequent techniques for foreign trade market expansion: a) Participating trade fairs, buyers/sellers getting together with

b) Meeting with the Representatives of the community business neighborhoods, trade groups and rooms

c) Holding clinical meetings

d) Appointment the representatives of the commercial sections of the Embassy e) Meeting the officials of the concerned regulatory authority. The exporters likewise take the following promotional actions for transact promotion: a) Incentive towards the local real estate agents

b) Appealing local agents for product sales meeting in the area

c) Setting up marketing office in the overseas

d) Connections with the regulatory authority as well as the ministry

e) Sponsoring participation of seminar of Doctors in Bangladesh f) Distribution of literature

Export incentives offered by the Government

There is no supply for money incentives in Bangladeshi pharmaceuticals exporting. Lately, this issue has become repeatedly reviewed within the stakeholders and they are definitely pursuing just for this cash bonus in order to stay competitive in the export marketplace. So far, the existing Export Policy of the federal government offers incentive that is relevant to all exporters including pharmaceutic companies: a) Value added taxes at 15% is free on the products produced intended for export; b) Any individual or perhaps organization may utilize foreign exchange for the purpose of export of any products

c) Tax is exempted in the case of corporate foreign trade income

d) In case there is “Deemed Export, VAT is totally exempted

Apart from the above incentives, different incentives intended for export are:

a) Foreign trade credit guarantee scheme for coverage for the exporter. b) Export credit rating guarantee for pre-shipment

c) Foreign trade Credit ensure for content shipment

d) Foreign trade payment Risk policy (Comprehensive guarantee)

e) Entire turnover pre-shipment finance assurance. The government has its plan but in fact a few will be being used.

f) Currency alteration facility (taka) under this system. Exporters should keep money in their account g) Foreign currency utilization facility

h) Exporters should utilize money carved through the farther foreign trade purpose. i) Export Advancement fund: the fund will be utilized to give assistance to the local manufacturers and then for export promoting, export variation and development of export of nontraditional things. These include going to seminar, built fairs, setting up sales centre in foreign country. j) Extension of export credit rating period via 180 days to 270 days. Length of Export credit rating under foreign trade development account has been prolonged up to 270 days. k) Export Loans: Credit card have been introduced to reduce risk of having cash dollars by the exporters. l) Limit of perimeter of export has been increased up to 90% i. at the. any céder can get loan about 90% from the contract price or L/C value. m) Credit for brand spanking new and fresh exporters is given if they will apply. n) Total flow o foreign trade credit will be maintained.

o) Export mortgage portfolio continues to be introduced by central lender to ensure regular export financing. p) Motivation will be succumbed case of export of new industrial products. q) 50 percent of the total export earnings will be tax exempted

r) Duty down side facility will probably be provided through commercial lender in order to keep the market price competitive. s) Bonded warehouse service for released has been prompted t) Capital machinery might be imported with no tax

u) Tax vacation provision should be imposed by the government

v) Sample for export: Limit for sending test for transact fair is US$ a couple of, 000 and other purpose the limit can be US$ one particular, 500. Sending sample through parcel content is increased at US$ 59. 00 w) Re-export: Permission is definitely not required from the MINISTRY of Commerce upon case to case basis and VALUE-ADDED TAX is decreased at five per cent from 10% x) Export as that L/C: Numerous be released on the basis of obtaining contract, arrangement, and purchase order to advance payment. In this case, the exporter needs to submit EXP Form and shipping bill. y) Transfer or advance payment L/C: L/C are not required in the event of import of capital equipment and standard raw materials and perishable item for re-export. z) Product Diversification Project: To keep export price by competitive level, arrangement will probably be made for duty draw back and cash motivation for export.

Export auto financing

No particular credit center or system exists to get financing export of pharmaceutical drug products. There was clearly an “Export Credit Assure Scheme for a lot of sorts of exports under the control and direction of the central bank, nevertheless the performance was not satisfactory. The scheme was targeted for overall industrial sector, but not specifically for the export of pharmaceutical items. However , the local and overseas banks working in Bangladesh had been supporting foreign trade activities of any kind through extending all their foreign operate services.

Authorities policy on export

On the whole, Bangladesh government strongly stimulates all kinds of export including Pharmaceutical drug products. Through the month of May 2004, the government modified ‘National Medication Policy’ to make it more conducive intended for the foreign shareholders as well as the neighborhood producers going to promote exports. Regarding rules of export of pharmaceutical drugs, the country’s existing “Export and Transfer Policy can be followed. The us government has ideas to expose more conducive policy to increase export of pharmaceuticals in near future.

Control promotion actions

1 . Foreign trade development services

In Bangladesh, there is no special transact promotion workplace or cell provinding foreign trade marketing and promotion services to get pharmaceutical sector. Export Promo Bureau (EPB) is the just public sector organization centered on extending number of export expansion and promoting services to facilitate the neighborhood exporters of all sectors. EPB provides information concerning export market and sets up activities associated with export advertising export industry development. Besides, there is a a lot more private asking houses that provides business solutions including promoting services. People are working since marketing agent or suppliers who explore export marketplace for local companies. Local consulting businesses are also planning the companies for export through quality documentation and other administration development. It can be expected that export advancement services will probably be developed in near future because the country will certainly enjoys tremendous benefits from the TRIPS after 2005.

installment payments on your Trade promotion activities

Recently, as i have said earlier, the Ministry of Commerce and Export Advertising Bureau in collaboration together with the sector affiliation of pharmaceutic companies i actually. e. BAPI have taken special initiative or program pertaining to export advertising of pharmaceutical drug sector. Activities like organizing control missions and group visits to international trade festivals, displaying pharmaceutic products in Bangladesh pavillion abroad and organizing buyers/sellers are the at this point regularly prepared by the Ministry of Business and Export Promotion Bureau and the trade bodies which include Federation of Bangladesh Compartments and Commerce and Industry (FBCCI).

Choices in matching standard and price in international market:

Now a days Bangladesh is a famous name inside the international marketplace for its standard of pharmaceutic products. The pharmaceutical sector competes with international company. Bangladesh have been trying to fulfill the national aspiration of turning its pharmaceutic industry in an céder of quality medicines. In mid-90’s some companies took initiatives to export

pharmaceuticals from Bangladesh. Today, Bangladesh is usually exporting the pharmaceuticals to various countries just like Singapore, Spain, Ukraine, Atlanta, Pakistan, Myanmar, Vietnam, Ceylon (veraltet), Nepal, Kenya, Germany, Yemen, Malaysia, Usa, Philippines, Sudan, South Korea, Bhutan and Hong Kong. You probably know that the internationally renowned hospitals & institutions like, KK Girls & Kids Hospital and Raffles Hospital of Singapore, MEDS of Kenya and Zinnah Hospital of Pakistan have been using the Pharmaceutical items of Bangladesh. Because, Bangladeshi pharmaceutical regular matched towards the international common. Bangladesh has become exporting a comprehensive portfolio of products masking almost all restorative classes and dosage forms. Apart from conveying tablet, pills, syrup, suspension system etc ., it also exports ‘High Tech and Specialized products’ like Metered Dose Inhalers (MDIs), Nose Sprays, Uvulas, Large Volume Potentials (LVP) and little Volume Possibilities (SVP). Bangladesh is now around the verge of entering remarkably regulated abroad markets like USA and Europe. With this connection, 3 major pharmaceutical manufacturers have previously made large investments in their new plants/factories. Price in international marketplace for pharmaceutical drug products is a lot higher than Bangladesh. Because the labor expense is lower than foreign sector. External price referring to (or intercontinental benchmarking) stands to affect the prices and availability of drugs outside the nation undertaking the benchmarking practice by reducing manufacturers’ motivation to set rates according to national marketplace conditions. This could have an adverse effect on cost and availability of medicines in smaller marketplaces and lower-income countries, which include lower-income countries in the OECD.

The practice of tallying to secret rebates may also have an external effect, because other countries using external benchmarking may well reference artificially high rates, resulting in list-price inflation. Claw-backs have an identical impact in that they mean the cost is successfully changed post-purchase (after the list price has affected a global price through external benchmarking). The convergence in list prices of pharmaceuticals which was observed in The european union (including Switzerland) and among European countries and Canada is usually consistent with what would be expected in a marketplace characterized by this sort of practices.

Function of transfers

All most all pharmaceutical companies procure unprocessed trash through indenting houses, except a few major brands. Formulations will be imported through the local agents of the overseas companies. However there are also direct Importers, Druggists and Chemists who import products intended for trading goal. In case of importance of recycleables and finished products, the local indenting properties and Clearing and Forwarding Agents perform an important part. In Bangladesh, the local importers of drugs and medicines are well organized. Conditions of import of unprocessed trash vary from product to merchandise as well as manufacturers. There is no limitation on quantity and variety depends on the requirements of specific companies. There is absolutely no restriction upon import of packing and packaging elements. Lead time of import will depend on country of origin and mode of transports. In case of Active Ingredients the provision for safety perimeter is three to four months (by sea) and 2 several weeks (by air). For Excipients safety margin provision is 6-8 several weeks if the transport is made by simply sea and 4 a few months (by air). For Finished products, it truly is 2-4 weeks. Four distinct modes of transport being used for transfer and these are by air, by ocean, by railroad and by highway. However , main parts of the imported materials are approaching by marine. Usual point of admittance is Chittagong (90%) and Mongla. Intended for import an excellent source of power but light and costly drugs, the local importers use air flow route usually. Some area of the importance is also approaching by highway through terrain border primarily from India

Packing and packaging supplies

Packing materials used in the local pharmaceutical sectors include aluminum foil (blister & strip), Alu alu foil, rubberized stropper, flip-off seal, printing materials, plastic cap, injectible, tear-off seal, tube, PVC, PVDC, level, bottle (white & color), plastic container, paper cartoon, producing materials, packets, etc . Nearly all packing material is regionally available except aluminum foil, alualu foil, PVC, PVDC, color containers, etc happen to be imported coming from countries like Korea, Lebanon, India, China and tiawan and so on.

Transfer duty composition and foundation valuation

Import work and other income taxes are incurred on equally Formulations and raw and

providing materials. Import duty about any active ingredient exclusively utilized for pharmaceutical products is several. 5%. In case of commercial import, the importance duty is definitely 15%. Value added tax is usually collected by 15% coming from all imports, but it is definitely adjusted later on on the basis of actual production output. Raw materials intended for products will probably be exported in the end require zero duty. Enhance Income Tax (AIT) is also recharged but to end up being refunded afterwards. Cost, Insurance and Freight (CIF) selling price of the components to be brought in is the basis of assessment of import duty and other taxes. This may differ in an excellent situation. Moreover to obligation assessment, tariff value is usually imposed. These kinds of tariff benefit is evaluated on the basis of the very best CIF worth of recycleables being brought in by different importers. Examination of tariff value depends upon what discretion of the customs specialist, and this varies from claim to claim and it is a determinant aspect of genuine landed expense of any imported materials. In addition , there is a supply for Creation Surcharge by 2 . five per cent of the CIF value. What is more, every transfer incurs fundamental costs which include license charge (0. 25% of the CIF value), L/C commission pertaining to opening page of credit (0. 3% to 0. 5% of the L/C value or minimum US$ 6th. 5), lender charges, and insurance superior at 1% of the C & F value from the materials being imported. The federal government Customs department through it is designated representatives assesses the importance of import in “local currency (Taka), based on the “invoice value.

SUMMARY OF NATIONWIDE DRUG COVERAGE (REVISED) 2006

1 . Regulations

Relevant Laws and Regulations commensurate with the prevailing circumstances usually control and regulate development, distribution, sales and utilization of drugs within a country and be sure that they are of good quality, suitable and safe. Presently, the Medications Act, 1940 (XXIII of 1940) and the Drugs (Control) Ordinance, 1982 (Ordinance Number VIII of 1982) control the process of enrollment, manufacture, division, sale, transfer and foreign trade of drugs in Bangladesh. These drug regulatory legal instruments of the country are now quite old. Lately, the medicine policy 1982 has been revised through necessary amendments to keep pace with newer advancements in the medication sector. Similarly, the Rules manufactured under the above Act and Ordinance also need to be

updated and integrated into some Rules.

In the event the functioning of these laws and regulations and their compatibility with other laws, possibly under the responsibility of the Ministry of Well being & Well being or other Ministries and Departments, affect implementation from the different aspects with the NDP, they must be amended consequently.

2 . Medicine Regulatory Specialist (DRA)

A strong management set-up is essential for successful management in the various aspects of the drug sector of the country. The Directorate of Drug Supervision of Bangladesh has been proposed to strengthen to effectively carry out the various capabilities of the regulating authority. The following measures have been taken:

we. The position of the Directorate of Medicine Administration (DRA) raised to this of the Directorate General of Drug Government ((DGDA) with corresponding increase in its personnel and infra-structure facilities.

ii. The organgram of the DGDA accommodates all lawful systems of drugs and regulate them under unified control.

3. The regulatory responsibilities continues to be decided to be delegated to different directors below DGDA to expedite and facilitate the functional operations.

iv. The decision-making techniques will be led by the goal, non-discriminatory and transparent suggestions and methods.

v. The staff of the DGDA will be properly trained, include clearly defined features and powers, and be entrusted with responsibility in relation to every aspects of sign up, manufacture, storage space, distribution, sales, import, export and top quality of drugs to be able to ensure conformity with the regulations, rules and regulations.

several. Drug subscription

All drugs and medicine and also other medicinal chemicals in finished dosage varieties, which are created, imported, allocated, marketed or perhaps consumed near your vicinity must be registered with the Drug Regulatory Power (DRA) with the country inside the specific dosage form and strength because recommended by the Drug Control Committee (DCC).

a) Number of drugs for registration

(i) Selection of a drug either for manufacture or import is one of the important capabilities of the National Regulatory Power (NRA). For this specific purpose the current approach to having a medication registration admonitory committee (DCC), which consists of experts and professionals coming from various exercises, will continue.

(ii) Top quality, safety, efficacy and performance will always be the predetermining requirements for endorsement for sale of pharmaceutical merchandise.

(iii) The Directorate General of Drug Administration, with approval from the DCC, shall select and make email lists of Necessary and nonprescription (OTC) prescription drugs following the WHO ALSO Guidelines and Model prospect lists of these kinds of drugs time to time.

b) Sign up criteria

(i) As a basic principle, enrollment for make, import and sale of combination drugs other than those of Unani, Ayurvedic & herbal plans, vitamins and nutritional formulations should not be allowed in the country. However , combinations like vitamins, healthy preparations and other drugs which are therapeutically beneficial and are listed in the developed countries, could be considered intended for registration. In the event of the Homeopathic system likewise, registration to get manufacture, import and sale of combination medicines shall not always be generally allowed.

(ii) In case of imported allopathic drugs, the manufacturing site will be inspected for GMP validation by inspectors from the drug regulatory

authority of Bangladesh. The examinations will be planned by the DRA and the concerned manufacturers will certainly bear the expense of any such inspection. However , the inspections will not be a club to the thought of a fresh drug app manufactured in a developed region included in the list of the Guard licensing and training Authority.

(iii) Bioavailability and bioequivalence data will be regarded as important criteria for the registration of any brought in medicine.

(iv) Any Unani, Ayurvedic or perhaps Herbal medication included in the formulary of various other countries, in the event that considered important and valuable by the National Unani, AYURVEDIC & Organic formulary Panel, may be awarded registration pertaining to manufacture and sale near your vicinity. National Unani, Ayurvedic & Herbal Formulary Committee will probably be constituted by government with the experts on Unani, Ayurveda and Herbal drugs.

(v) Single registration for Mom Tinctures, Mother Triturations and 12 bio-chemic and their 1X potencies of the homeopathic system may be allowed.

(vi) Biochemical products will probably be registered by Licensing Authority (Drugs) based upon their protection, quality and usefulness.

(vii) Liquid serving forms of unani, ayurvedic and herbal ayurveda and organic drugs which contain up to five per cent (v/v) of 96% ethanol may be permitted to be signed up, if make use of such excessive proportion of ethanol is totally needed for their very own better efficacy and keeping quality. Yet , in outstanding cases, use of ethanol up to and including maximum volume of 10% (v/v) may be allowed, if recommended by the DCC.

(viii) Certain drugs, regardless of their regarded serious side-effects and probability of being abused, may be signed up for importance, production and sale in limited quantities for limited use.

c) Registration method

The present procedures followed for subscription of drugs of all

acknowledged systems, as specified inside the existing laws and regulations, should continue after changing or updating them since appropriate. But , efforts should be made to develop methods for expediting the processes of registration.

4. Drug creation

(i) One of the main objectives of the NDP is to produce good quality medicines in the country. The latest Good Developing Practice (cGMP) guidelines of WHO ought to thus always be strictly implemented in the production of drugs near your vicinity. In order to ensure strict compliance with the requirements of cGMP, all medication production devices should be controlled by regular inspection by the Inspectors of the Directorate of Medicine Administration. The will also be expected to conduct routine internal cGMP audit following standard “Check-list of the Directorate of Medicine Administration.

(ii) Another primary objective with the NDP should be to ensure self-sufficiency in all types of drugs. Therefore , all required measures needs to be undertaken to make sure that the current trend of elevated rate of local production of drugs can be sustained and additional improved.

(iii) Priority should be given to development of sufficient quantity of important drugs. Initiatives would be made to ensure that every one of the essential medications and non-prescription (OTC) prescription drugs (lists n which are appended to this policy) are manufactured in the area in enough quantities and they are available at affordable prices.

(iv) Foreign and multinational companies will probably be allowed to invest and production drugs in Bangladesh given that they have for least three of their first research product. Drugs listed in for least two of the following countries: USA, UK, Switzerland, Indonesia, France, Asia and Australia.

(v) Production of drugs that are not included in the last five editions of the Uk or United states of america Pharmacopoeia (USP) or Worldwide Pharmacopoeia (IP) or the English Pharmaceutical questionnaire (BPC); or in the WHOM lists of the International Non-proprietary Names (INN), will be prohibited.

(vi) In order to encourage copy of technology and availability of the newly developed prescription drugs, foreign companies, with or without having manufacturing plants in Bangladesh, will be allowed to manufacture drugs in the country under licensing agreements with any kind of partners of their choice.

(vii) The task of producing Unani, Ayurveda and Herbal drugs can lie entirely with nationwide manufacturers with a view to attaining self “sufficiency in respect of community resource primarily based drugs.

(viii) Both neighborhood and foreign companies having manufacturing plants in Bangladesh will probably be allowed to companies drugs underneath toll as well as contract manufacturing arrangements any kind of time other manufacturers o their choice.

(ix) For the purpose of foreign trade only, any drug may be allowed to always be produced in the region in accordance with the actual requirements with the importing nation.

5. Drug procurement

(i) Prescription drugs and pharmaceutical drugs may be obtained by community purchase or import, and by receiving while donation or perhaps gift.

(ii) Drugs for personal use of individual patients or to meet any national unexpected emergency situation or for the purpose of study and trials or for just about any other certain use, which are not listed, may be imported with prior approval with the Licensing Specialist (Drugs) for specific volume and for noncommercial purpose.

(iii) Importation of any drug that is produced in the in enough quantity will not be allowed like a measure of safety for the local industries. However , if community production of any medicine falls in short supply of need for any reason, or in case of urgent arises, this condition may be relaxed by the Government for a particular period.

(iv) Any simple pharmaceutical natural material, which is locally stated in sufficient quantity, will be presented protection by simply disallowing transfer of this

raw material or it is substitute near your vicinity. However , in the event needed for foreign trade purpose, importation of this kind of pharmaceutical recycleables will be allowed in competitive prices through international tender.

6. Medications distribution, sales and storage area

Quick and safe circulation and honest sale of drugs from public/ private safe-keeping facilities towards the end “users should be made certain so that the quality of the items is taken care of throughout the complete process and good quality important drugs are available to those who need them.

(i) The particular drugs, that are registered in Bangladesh, needs to be allowed to always be distributed and sold in the.

(ii) No Person without having professional qualification or holding valid professional certificate should be in order to stock, distribute or sell off drugs and medicines.

(iii) No medicines or medicines, other than non-prescription (OTC) prescription drugs, should be distributed or furnished without prescriptions.

(iv) Repair of quality and safety of medication in stores and in safe-keeping should be ascertained by carrying out regular inspections by Inspector of drugs within the quality of stored prescription drugs at all levels.

7. Medicine pricing

(i) Realistic pricing of drugs should be made certain to make essential drugs open to the endusers at affordable prices.

(ii) The current approach to controlling prices of frequently used essential medications should be extended and the existing list of the prices-controlled medications should be updated in the light of current pattern of changes of medication used in the principal healthcare.

(iii) The existing system of linking rates of locally produced prescription drugs with costs of organic and packaging materials which of imported finished drugs with

landed expense should be modified for rational fixing of Maximum Full Prices (MRP) of drugs.

almost eight. Quality assurance of medication and pharmaceuticals

One of the most important objectives of the NDP is to generate good quality drugs available at affordable prices. In order to accomplish that objective, quality building within a drug with the manufacturing level by in process top quality control and quality keeping in the drug in transportation and safe-keeping should be made certain by assessment it for different stages before that reaches the end “users.

(i) Each pharmaceutical company needs to have a quality control and the good quality assurance system, which will would monitor the entire procedure form the acquisition of raw material to the conversion right into a finished item.

(ii) Every single Manufacturer really should have a dedicated team of professionals intended for adequate item and procedure design and statistical control of the process through in- procedure and end- product assessment.

(iii) There should be documented Regular Operating Treatment (SOP) based upon WHO advised cGMP guidelines for production of each product as well as for every single manufacturing unit procedure.

(iv) Each of the unit method should be regularly validated to assure correct end “results. The validation results should be properly documented.

(v) Qualified professionals related to pharmaceutical drug sciences should be employed in every one of the relevant departments, related to top quality control and quality assurance, of a manufacturing plant following the guidelines of WHO to be able to ensure creation of good top quality drugs.

(vi) Quality of marketed prescription drugs should be guaranteed by regular post-market cctv surveillance by the Medication Inspectors and testing random samples of the marketed prescription drugs in the Top quality Control labs.

(vii) Besides the QC labs of the businesses there should be 1

Central Drug Testing/ Quality Control Laboratory and a number of Local Drug Testing/ Quality Control Laboratories under the Directorate of Drug Administration with separate units for unani, ayurveda, herbal and homeopathic-biochemical prescription drugs, manned by simply technical professionals of the particular disciplines.

being unfaithful. Manpower of the manufacturing models

(i) Most manufacturing models should be well staffed with satisfactory number of Pros related to Pharmaceutic sciences in accordance with WHO recommendations in order to develop good quality, safe and effective drugs and pharmaceutical.

Yet , the unani, ayurvedic, organic and homeopathic-biochemical drug making units should be staffed with adequate quantity of Qualified people of the particular disciplines and, where important, pharmacists, chemists/ biochemists, and botanists.

(ii) Persons with relevant requirements should be employed in the various departments of the manufacturing units following the guidelines of WHO and strictly pursuing the relevant laws of the region.

(iii) Adequate number of different supporting educated and skilled technical workers should be used for smooth functioning of the manufacturing plant.

10. Medication information and monitoring

(i) The Directorate of Medication Administration should have a well-equipped Drug monitoring and information Unit.

(ii) Data upon production, import, export, procurement storage, division and deal should be compiled, monitored and evaluated to ensure availability of medication at all levels of the country’s health care facilities at public and private sectors.

(iii) Safety, efficacy and top quality of all signed up drugs ought to be monitored regularly and information about any low quality, spurious and counterfeit medicines should be manufactured freely available to all worries by extensive publicity in both produce and electronic media.

(iv) Rational utilization of drugs (RUD) should be ensured by executing surveys on the systems of prescribing, dispensing and sufferer compliance.

(v) Monitoring and reporting of adverse reactions of drug (ADR) should be really done to assure safe and rational utilization of drugs in the area.

(vi) Objective and educational advertising of nonprescription (OTC) drug based on clinically established data and in great taste can be allowed with prior acceptance of the Drug Regulatory Expert (Current prospect lists of OVER-THE-COUNTER drugs of allopathic, ayurvedic and unani systems happen to be appended to this Policy).

11. Essential medicines

There will be a List of Important Drugs to get Bangladesh. The Directorate Basic of Drug Administration shall update as well as the list of essential drugs in line with the present list of Necessary Drugs worldwide Health Organization.

IPLC ISSUE:

Like organizations in other industrial sectors, pharmaceutical producers try to improve profits from their operations. Since unit creation costs can be considered independent of the level of production, making the most of profits translates into maximizing positive cash moves during the lifestyle of a item, and particularly during the period in which the product benefits from industry uniqueness.

To be able to meet this objective, a pharmaceutical maker will kick off as quickly as possible inside the markets with all the highest product sales potential (in

terms of amount and prices), will cost its products of up to possible relating to market circumstances and regulating constraints, will attempt to extend the time of marketplace uniqueness, embark on promotional actions to capture while large some the market as is possible and seek to expand the potential market for its products.

Worth edition:

The pharmaceutical sector of Bangladesh in right now capable of manufacturing drug products by getting together with their finest quality standard. It maintains substantial standard of Quality Assurance in manufacture and control of medication and medication products. A reliable regulatory known as the Directorate of Drugs Administration. And the Manufacturing facility and practices while using requirements of CGMP (Current Good Production Practice) and regulations. Bangladesh has making facilities appointment the highest CGMP requirements. Quality Control Labs are equipped with complex equipment and meet the requirements of CGMP. Specifications and test techniques for raw materials and drug products are based on English Pharmacopoeia (BP), United states Pharmacopoeia (USP ) and Western Pharmacopoeia (EP). Good Production Practice (GMP) is the basic concept pertaining to maintaining top quality control of done drugs and medicines. A number of pharmaceutical businesses in Bangladesh received internationally acclaimed “ISO 9001 & 9001: 2000 Certificate in recognition with their quality. Intended for achieving this sort of recognition the door has been opened and has got access to the Asian, Western & Africa market pertaining to Bangladesh items. Quality Assurance Program in place ensures that the facility, equipment, process and check methods happen to be validated and instruments happen to be calibrated. Qualified and skilled personnel are employed in the manufacture and screening of medicine products. Products are introduced only after review simply by Authorized person and that raise the value from the product. With regards to raw materials finding, the pharmaceutical manufacturers in Bangladesh procure raw materials coming from various countries namely UK, France, Philippines, Japan, Holland, Italy, Denmark, China, Swiss, Austria, Hungary, India, Ireland etc ., In the case of raw materials which can be locally manufactured, we do not choose import.

Regulating environment and up to date changes in the National Drug Insurance plan

In order to guarantee adequate supply and availability of good quality vital drugs at affordable prices, a major and far-reaching National Medication Policy (NDP) was created in 1982. Following the guidelines of the NDP, a Drug (Control) Ordinance was also promulgated in the same year. Both of these documents created tremendous positive effects on fast development of the neighborhood pharmaceutical sector and progressive improvement inside the drug sector for the region. After having 22 years of steady growth in the local drugs industry sector, the government and other stakeholders updated and customized the plan through addition of new elements in order to properly deal with all of the changes and creation that have occurred so far. Accordingly, the Countrywide Drug Insurance plan 2005 has become formulated meeting the current demands of the country as well as the global business environment. Revised National Drug Coverage 2005 provides focused on the next:

¢ Applicability, effectiveness and flexibility to the latest remarkable technological advancement inside the medicine world. ¢ A competitive medicine sector to do better in the world market ¢ A brand identity in the world being a producer and exporter of quality medicines.

The revised policy strengthened more specialist to the Directorate of Medication Administration (DDA) through changing it in to Directorate General of Medicine Administration (DGDA), which will reduce bureaucracy in a single sense and speed up work under the same roof. All modern establishments planned to get created for assessment and other reasons and the officials will be trained on newest tools and techniques in so that it will improve regulating environment as well as to deliver quality services for the industry. The modern policy will also help better and strict monitoring of against the law activities and malpractices in the industry. It is even more open to the multinational firms who have an interest to undertake ‘research and development’ for generating improved quality and ground breaking drugs. This kind of policy will help with setting up of plant for producing raw materials i. electronic. active ingredients by local and foreign shareholders. There is also dotacion for Fee or agreement manufacturing, certified manufacturing, franchising and other features to attract the

international investors.

Research and development

The key pharmaceutical corporations have been in a position to bring advanced technology from created countries. So far, there are simply no research studies on the “new molecule in Bangladesh, while there is continuous development of Formulations. Recently, one firm has set-up a plant to produce anti-cancer hormone and specialized goods. Companies have their product development staff who continuously undertake ‘Research and development’ activities. Prevalent research and development activities are as follows: a) Bibliographic search assisted by useful resource libraries

b) Design and selection of process maximizing effectiveness

c) Environmental influence assessment lowering

d) Accelerated and longer balance testing

e) Merchandise quality search engine optimization and

f) Translation of new scientific insights in the products. Services have been conducting study upon vaccine for critical disease like anti-cancer, antidiabetics, etc . in collaboration with foreign experts. Many investigations are also getting carried out to make herbal medicines. Products development goes on continuous basis in several companies no matter their size. There is a good progress in raw materials development in cooperation with the western countries. Test method is developed and validation is done in line with the British Pharmacopia and ALL OF US Pharmacopia. Likewise, stability analyze and approval of method is carried out for new Formulations. Since the get-up packing supplies and packaging is very important pertaining to export advertising, companies exports take extra care pertaining to modern and standard packaging system with attractive printing materials and convenient storing and handling options.

Realization:

Bangladesh is one of the weakest countries on the globe where about 80% in the population are living below poverty level. Therefore , ‘malnutrition and poor health conditions’ exit. On the contrary, the country is likewise developing day by day, per household income is growing and the getting power of the normal

persons is increasing slowly but steadily. In 2005, the per household income is definitely US$ 470, which was only US$ 376 earlier. Since the population growth is still there and gradual embrace health mind among mass people. These factors have positive impact within the demand of the pharmaceutical goods. As a result, the need for brought in raw materials is likewise increased. The pharmaceuticals sector is the second largest sector after farming that contributes to the earnings generation with the Bangladesh Government. The sector has expansion potentials at local and export market. There is an increasing trend inside the export of pharmaceutical sector that implies very great future leads for the nation. In the local marketplace, there is a growing demand for drugs for anti-cancer, anti-hypertension, anti-diabetics, AIDS, cardiovascular, different vaccines etc . To date, the local pharmaceutic companies are not really producing medications for critical diseases just like cancer, HIV/AIDS, diabetics and so forth Recently, there are few endeavours and jobs to produce quality drugs from the above classes, but it will require some time to create these products avilable in the local marketplace.

Traditionally, we have a common opinion that herbal medicines do not have any kind of side effect. A huge majoirity of individuals living in country Bangladesh are still traditional within their attitude. This segment of folks demand normal products for all kinds of diseases. So , there is significant potential marketplace for herbal products in Bangladesh. The demand of pharmaceutical raw materials has grown in the the past few years and will maximize further inside the coming years since the production volume of the neighborhood companies is usually increasing day by day due increased local consumprion and foreign trade. As of now, the area companies are exporting to 62 countries really worth US$ twenty-one. 26 million, which was just US$ doze. 69 , 000, 000 in 2005, export increased at 60%. So , while using increase in export of drugs, the requirement for unprocessed trash will be larger. But , there have not been enough initiatives to produce uncooked materails in your area except 4-5 companies that undertaken tasks recently. To ensure smooth supply of raw materials, the us government is determined to set-up professional park for production from the active pharmaceutic ingredients in Dhaka instead of earlier strategy in Chittagong. Although the federal government regulates the organization of this sector including consumers’ price, the recent insurance plan change by government offers tremendously improved the scope for new buyers and multinational companies to purchase both formula and API sector. There are some 68, 000 registered Pharmacists in the country who sell pharmaceutical products in retail level. It is estimated that one more 56, 000 Pharmacists happen to be operating in the retail market and are yet to get registered. The marketing people today belonging to the majority of the local companies are involved in “push selling. Since multimedia campaigning and advertisement is prohibited, product sales promotion is done through providing incentives towards the field level sales force as well as to the doctors. After eyeing huge industry prospects, several new companies which includes foreign owned or operated have created the market with the manufacturing plants to get formulations. The current leading firms (Beximco, Sq ., etc . ) have also invested large amount of fund in the sector. Causes are the long term scope of opportunities resulting from Trade Related Intellectual House Support (TRIPS) after 2005 and to adhere to the increased WHO specifications to be enforced in near future.

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