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September 8, 2016

Ensuring quality drugs


September 8, 2016

Some recent credible investigations by the Punjab government into the quality of locally-manufactured drugs show that those people who keep complaining about the low quality of medicines in our country are not that cynical after all.

According to Adviser to Chief Minister of Punjab on Health Khawaja Salman Rafique, the Punjab government recently got 50 samples of different local medicines by a reputed drug testing laboratory in London and found that 15 of them were deficient in the main curative substance aka active ingredient. These specimens contained 5 to 12 percent less than the specified quantity of the active ingredient. The drugs by the same companies used to get a clean chit by the local laboratories.

These findings in Punjab provide a glimpse into what may be happening in the pharmaceutical sector in other parts of the country as well. Regulatory laws for ensuring the quality of manufacturing and trade of medicines exist but the enforcement is very lax. As a result, the market is proliferated with sub-standard, spurious and adulterated medicines. The situation is worse in small cities and villages.

There is not a single drug testing laboratory in our country that fulfils the standards of the World Health Organisation (WHO). There are five such laboratories in Punjab alone and none up to the mark. When it comes to building motorways and flyovers, money comes easily, but health facilities and projects remain under construction or dysfunctional for want of funds for years and years, in some cases for a decade.

Above all, whatever little institutional capacity the country has is nullified by widespread corruption by government officials. Unscrupulous elements among the pharmaceutical manufacturers get their sub-standard products approved by local laboratories by greasing the palms of the officials overseeing the process. There are now protests over drugs being tested from abroad.

The issue not only relates to medicines with a low active ingredient, but also adulterated medicines and spurious drugs having almost zero quantity of the main salt or containing expired active ingredients.

For instance, in June this year, the Federal Investigation Agency (FIA) impounded a large quantity of drugs in Lahore which the laboratory found to be spurious. These medicines, bearing the monogram of the Punjab government, were being supplied to government-run hospitals. The accused company was doing business on a fake registration document.

Last month, the Punjab health department found that 10 pharmaceutical manufacturers were using an expired active ingredient and flouting several essential guidelines given in the Good Manufacturing Practice (GPM), which is the international standard of manufacturing pharmaceutical products. The provincial government has now written to the federal Drug Regulatory Authority of Pakistan (DRAP) for cancellation of the licences of these firms.

The authorities have been quite lenient in enforcing the GPM on drugs manufacturers. Not a single pharmaceutical company in our country has been approved by the Federal Drug Authority (FDA), which is considered a mark of quality worldwide. In contrast, 60 pharmaceutical firms of India and four of Bangladesh are endorsed by the FDA.

Owing to use of adulterated and spurious drugs, many fatal incidents have occurred. In January 2012 more than 100 heart patients lost their lives in Punjab after using a locally-manufactured drug dispensed to them by the government-run Punjab Institute of Cardiology (PIC), Lahore. The drug was afterwards found to be heavily adulterated with a compound meant for treating malaria.

In November the same year, a cough syrup imported from India was blamed for claiming more than 30 lives in Lahore and Gujranwala. After four years of these horrible incidents the Punjab government has now started checking drug quality at retail outlets and manufacturing units.

The existing drug regulatory law defines the terms ‘sub-standard’ and ‘spurious’ In less-than-satisfactory manner The law states that any drug containing one percent of the totally specified active ingredient would be considered ‘sub-standard’ while a drug with less than one percent of the active ingredient is deemed ‘spurious.’ This means that if a person takes an antibiotic with a specified strength of 500 mg and it contains an active ingredient of only 5 mg, it will be considered only ‘sub-standard’. If the same drug contained half of the specified amount, it would not be considered ‘sub-standard’ as per law.

The Punjab government has drafted a new bill for fixing the shortcomings of the law but the association of pharmaceutical manufacturers, as expected, have opposed it due to which the bill is still pending. The effective regulation of drug manufacturing and trade constitute a big issue in our country; this industry involves a business of Rs140 billion per year with astronomical profits; and corruption among government functionaries is widespread.

The drugs manufacturers’ association is unhappy over the ongoing drive in Punjab. The association has demanded that all tests should be conducted only in local labs. It also does not want criminal cases registered against the wrong-doers. The association says the maximum punishment for the manufacturers of sub-standard or spurious drugs should be that the drug is recalled from the market.

The manufacturing and trade of drugs is not just a business; it is a matter of life and death for people. The government must resist pressure from vested interests and legislate what is appropriate for the public besides taking stringent measures to enforce the law. Drug manufacturers and traders have become used to lenient enforcement of the law. It would require a sustained effort on the part of the government to discipline them.

Email: [email protected]


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