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 “azathiopring.” Upon testing, the tablets failed the quality specification for disintegration time. The tablets were still intact after four hours in water at 37 °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.
