Pharma sector forcing off the pace

[CaPtAiN_pLaNeT]

Pharma sector forcing off the pace

Beenish Qaiser

Pharma sector forcing off the pace

Bangladesh, a country that was previously known for natural resource based sectors like textiles and jute in the business world, has now emerged as one of the fastest growing pharmaceutical exporting nations. After tobacco, pharmaceutical is the second largest revenue generating industry in Bangladesh, and the country looks well set to merge as a global hub for quality medicines The $700 million industry with more than 230 manufacturers is continuously expanding, rising to new heights with new and improved products. Out of the 230 companies, 200 run their own manufacturing facilities, out of which five are multinationals.

Now approximately 97 per cent of the domestic pharmaceutical demand is met by the local companies. Pharmaceutical products from Bangladesh are a name in the international market, being shipped to over 72 countries around the world such as USA, Latin America, UK as well as its neighboring Asian markets of Nepal, Myanmar, Sri Lanka, Pakistan, India, Thailand and China. Pharma companies are now trying to squeeze their way into the European and African markets. The secret of prosperity for pharmaceutical companies in Bangladesh lies in unparalleled potential for future growth triggered by an acquired edge over their competitors in a number of factors.

First, the industry’s ability to comply with quality control guidelines has enabled them to score a secure platform for themselves.

The industry confirmed over 50 new factories in the last three years and almost all of them are equipped with World Health Organization’s (WHO) Good Manufacturing Practice (GMP) standards.

The sector is also operating in API (active pharmaceutical ingredients) with which twenty-one different companies are now locally manufacturing about 41 API’s.

However, more API industries need to be set up to meet local demand.

At present, Bangladesh imports 80 percent of its pharmaceutical raw materials. At the same time, skilled professionals both native and foreign are joining the pharma sector every year.

Bangladesh has been granted permission by the World Trade Organization (WTO) to reproduce the patented products up to year 2015 as per trade related intellectual property rights (TRIPS).

Thus, pharmaceutical industries are now legally allowed to reverse engineer, manufacture and sell generic versions of on-patent pharmaceutical products for domestic consumption as well as for export to other LDCs. This has made Bangladesh a valuable chemical entity. With about 40 years of experience in pharmaceutical formulation and marketing Bangladesh is now fully trained to help both LDCs and developing countries if required.

Apart from the regular investment in pharmaceutical industries and API, opportunities of bioequivalence study, validation report, clinical trials and manufacturing plant audit mechanisms have been created within Bangladesh and are becoming a source of attraction for more and more foreign investments. Some of the companies including Square Pharma, Renata and Eskayef have already won accreditation from the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA).

Incepta and Beximco Pharma have been accredited by EMEA ( Austria ) and the Therapeutic Goods Administration (TGA-Australia), respectively.

These accreditations will allow them to enter the lucrative market with competitive prices and unsurpassed standards as recognized global antagonists.

This in turn has cultivated a wide range of opportunities for the industry whereby these Bangladeshi companies can now export pharmaceutical products to any part of the world.

The leading pharmaceutical companies in the country such as Advanced Chemical Industries (ACI) Limited, Square Pharma, GlaxoSmithKline Bangladesh Ltd, Beximco Pharmaceuticals Ltd, etc, now possess adequate amenities to produce tablets, capsules, injectibles, liquids, suspensions, sustained release dosage forms, dry powders metered dose inhalers, sterile ophthalmic formulations, HFA, inhalers, suppositories, hormones, steroids, oncology, immunosuppressant products, nasal sprays, creams and ointments.
The major drugs commonly produced in bangladesh include paracetamol, diclofenac, ampicillin and amoxycillin among numerous others.

In recent years, the country has achieved autonomy in large volume parenterals, some quantities of which are also exported to other countries.

Imports constitute about five per cent, including finished formulations like vaccines, latest anti-diabetics and anti-cancer drugs.

Under the Drug Control Ordinance of 1982, the government fixes the maximum retail prices (MRP) of 117 essential drug chemical substances while the non-essential drugs are priced through an indicative price system.

This rule however, is only applicable to the locally manufactured products. For imported finished products, whether they fall in the category of vital or non-vital drugs, a fixed percentage of markup is applied to the C&F price to obtain the MRP.

Observing a unique evolution in the physical distribution of pharmaceuticals in Bangladesh, even with the withdrawal of price control from several drugs, healthy competition, consistent demand and foreign investment has enabled the prices to remain stable and with in reasonable levels.

Unlike other countries Bangladesh pharmaceutical industry is more retail oriented and thus, mass distribution is done by the companies themselves through their own warehouses to retailers as well as wholesalers.

The sector holds a strong foundation due to the heavy local demand for medicines.

The industry’s production of quality medicines at an affordable price for millions of people in Bangladesh have made it almost self reliant in pharmaceutical products.

Increased affordability and availability of medicines has made basic as well as most of the high end medication accessible to the common man in a poverty struck nation like Bangladesh.

Examining the current pharmaceutical scenario of Bangladesh, where the National Drug Policy of Bangladesh encourages the local production of raw materials and majority of the drugs within the country offering extensive opportunities in this direction, the future appears bright and propitious.

Despite having one of the lowest annual per capita drugs consumption in the world, Bangladesh still banks on the pharmaceutical industry for extensively contributing to its economy.

According to the business forecast by the US-based pharmaceutical consulting firm Amreteck Pharma LLC, the country’s pharmaceutical sector is expected to grow by 13 per cent this year.

Pharmaceutical companies in Bangladesh should be encouraged to avail the golden opportunity of learning and amalgamating assistance from their international counterparts or investors to establish an ingenious and articulate research and development division in the country.

Organizing seminars, conferences and workshops contingent on pharmaceutical industry knowledge and information for creating successful entrepreneurial leaders and managers in Bangladesh can be an effective step towards growth.

With the development of medical and healthcare infrastructure, optimization in health awareness, rise in public purchasing power, this industry is expected to grow rapidly in the future.

The industry’s inception dates back to the 1950s when a few multinationals and local entrepreneurs established pharma laboratories and factories. With the implementation of the Drug Control Ordinance of 1982, Bangladesh ’s pharma industry transformed from an import based, to a self-sufficient and export-based economy.

 

[M.AKRAM NIAZI]

Analysis of Countries from Where Drugs are mainly imported:
Finished drugs are mainly imported from neighboring countries China, India and in some extent from Bangladesh. Therefore it is necessary to analyze their own import policies to know that how they are protecting their local Industry and status of compliance of their Industries to GMP and regulatory requirements

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India

For Protection of Local Manufacturer following measures
Were taken By Indian Government.
Industrial licensing for the manufacture of all drugs and pharmaceuticals has been abolished except for bulk drugs produced by the use of recombinant DNA technology, bulk drugs requiring in-vivo use of nucleic acids, and specific cell/tissue targeted formulations.
For Restricting Imports following measures
Were taken By Indian Government.
• Ministry of Health and Family Welfare will enforce strict regulatory processes for import of bulk drugs and formulations.
• For imported formulations, the margin to cover selling and distribution expenses including interest and importer’s profit shall not exceed fifty percent of the landed cost.
• Due to Government policies and low cost of domestically produced drugs and the absence of patent rights regulations has made the Indian Market less attractive for foreign companies.
Quality of Indian Medicines.
“Counterfeit drugs could be the single biggest problem in India in the next ten years due to the growth of garage-based drug manufacturing outfits, rampant corruption, and weak drug control,” A 2003 Scrip report estimated that 15 to 20% of the medicines sold in the country are counterfeits. A case study reported in a 2001 conference showed the following percentage (out of 125 tracer medicines) that failed quality testing: 6% from the public sector, 12.7% from the private sector; and 0% from NGOs.
In 2001, Lancet reported that, according to WHO statistics, India produces as much as 35% of the fake and substandard drugs in the world. A powerful group of manufacturers have taken over much of the production during the past three years. It is reported that these Counterfeit drugs are manufactured mostly in the northern states; but these fake drugs are widely available throughout the country. They are available as well in Myanmar (Burma) and Cambodia, and their distribution may even extend as far as the former Soviet states, as evidenced by the arrest of four Uzbek women caught trying to smuggle them to be sold in their country. (Ref: 2004 The United States Pharmacopeial Convention, Inc. A Review of Drug Quality in Asia with Focus on Anti-Infective).
India was among the six countries that participated in a drug quality study which collected a total of 71 samples of the antituberculosis drugs isoniazid (INH) and rifampicin (RMP) as a single entity or a fixed-dose combination (FDC) (see Multi-country studies). Overall, 10% (4/40) of all samples obtained from all six countries, including 13% (4/30) RMP were substandard, containing < 85% of stated content. More FDCs, 21% (5/24), than single drug samples, 13% (2/16), were deemed substandard.
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China.
Quality of Chinese Medicines:
According to the SDA, a nation-wide survey on the quality of medicines carried out in 1998 found that 13.1% of the 20,000 batches tested were either counterfeit or fell below minimal pharmaceutical standards.
In 1997, China News Digest reported that the Health Ministry of China inspected 1100 medicines and found 138 products that failed to meet national standards. Of these, 48 were fake medicines with pirated registration numbers.
At the 2002 Global Forum on Pharmaceutical Anti counterfeiting held in Geneva, Switzerland, a representative from the Glaxo SmithKline (GSK) pharmaceutical company reported on the counterfeiting of two of their products in China. The first was Imuran tablets. The counterfeit Imuran was found to contain the correct amount of azathioprine, the active ingredient; however, the tablets were labeled incorrectly as &#8220;azathiopring.&#8221; Upon testing, the tablets failed the quality specification for disintegration time. The tablets were still intact after four hours in water at 37 &#176;C, while genuine tablets dissolve in 45 minutes. The other drug was Zinacef tablets. The genuine oral dosage form contains cefuroxime axetil; the counterfeit Zinacef tablets revealed the presence of cefuroxime sodium, the injectable dose form. When taken orally, cefuroxime sodium is absorbed minimally by the digestive system resulting in no therapeutic benefit.
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Bangladesh.
For Protection of Local Manufacturer following measures
were taken By Government.
1. The importing of a drug which is the same or one produced in the country, or a close substitute for it, may not be imported, as a measure of protection for the local industry. However, if local production is far short of need, this condition may be relaxed in some cases.
2. A basic pharmaceutical raw material, which is locally manufactured, will be given protection by disallowing it or its substitute to be imported if sufficient quantity is available in the country.
3. No foreign brands may be manufactured under license in any factory in Bangladesh if the same or similar products are available/manufactured in Bangladesh.
4. No multinational company without their own factory in Bangladesh will be allowed to market their products after manufacturing them in another factory in Bangladesh on a toll basis.
Restrictions on patent rights discourage foreign investors to come up actively in the pharmaceutical market in Bangladesh. Moreover introduction of new molecules is difficult due to slow registration process and restrictions.
Quality of Medicines from Bangladesh:
Among the total 245 pharmaceutical manufacturers only top 20 leading manufacturers are producing good quality medicines in the country and most others are engaged in the production of substandard or fake drugs. Substandard or fake versions of life-saving drugs are alarmingly prevalent in Bangladesh markets. In some cases, it is around 70% to 80%.
One media report showed that among all the pharmaceutical manufacturers only 20 to 25 companies are producing quality medicines in the country. The situation clearly raises a question about the role of the remainder manufacturers.
They are mainly involved in the production of fake/substandard or imitating renowned brands of various drugs. At present, spurious drugs have been flooded all over Bangladesh. Another testing conducted by the drug regulating body found 69% paracetamol tablets and 80% ampicillin capsules as substandard from some small manufacturers.
A recent assay involving 15 brands of ciprofloxacin showed that 47% of the collected samples containing active ingredient less than the required specification.
In a survey conducted during 1988-91, it was found that 66 of the 198 licensed manufacturers were each producing between 1 and 16 substandard drugs (49% OTC drugs and 6.3% injectables, the remainder being non-injectable prescription drugs). Of the OTC products, about 36% was paracetamol and 41% consisted of antacids. The content of the active ingredients was found to be insufficient.
In 1992, quality studies were conducted on paracetamol tablets, ampicillin capsules, cotrimoxazole tablets/suspensions, vitamin B-complex tablets/capsules/injectables, and vitamin B-2 tablets. A total of 137 brand samples of these drugs were obtained from retail shops in various parts of the country and analyzed for level of content of the active ingredients as well as the disintegration of tablets. Results showed 37 samples were substandard, all manufactured by small companies. Of the 16 brands of paracetamol tablets and 10 brands of ampicillin capsules that were substandard, 11 and 8 respectively, had previously been considered substandard in an assessment conducted by the regulatory authority. This holds true also for the two brands of cotrimoxazole suspension found to be substandard. All analyzed products for 13 of the top 15 companies in Bangladesh met the required standards.
A recent case study involving a sample of 15 brands of ciprofloxacin collected for chemical assay by HPLC and bioassay revealed seven brands containing active ingredient less than the USP specification.
(Ref: 2004 the United States Pharmacopeial Convention, Inc. A Review of Drug Quality in Asia with Focus on Anti-Infectives )

Conclusion:
From all above analysis it is clear that importing Drugs from these countries will be not only harmful for the economy but also dangerous for the health and safety of the nation.

Therefore, it is needed to restrict import of Low Quality Finished products specially from India and China or any other country by levying Protection duties on products which are produced locally and measures should be taken to improve growth of Local Pharmaceuticals as well as to promote exports of Pharmaceuticals.

M.AKRAM KHAN NIAZI.

Karachi,Pakistan.

 

[fallstuff]

^^ Niazi whats the source of your article ? Are you the author ?