New Delhi: Amid mounting questions about lax regulations involving fake drugs produced in India, a national survey commissioned by the World Health Organization (WHO) has concluded that some 3% of drugs in the market are counterfeit or spurious, well below the 10% average for such fake medicines in most developing countries.
The survey, conducted by the International Pharmaceutical Federation (FIP), comes at a time when the government has promised to introduce a Bill in the current session of Parliament that will call for stringent punishment for those engaged in the manufacture and sale of spurious drugs.
The WHO-backed survey precedes a mammoth exercise being planned by India’s drug regulator to also map the extent of this problem in the country.
The survey picked up 10,000 samples of 56 top selling drugs, as ranked by market researcher ORG IMS. Of the 3% of the sample that was counterfeit—defined as those violating patent and copyright rules by, for instance, mimicking packaging and brand names—the study estimates that just one-10th are likely to be substandard in terms of their ingredients.
The survey also found uniformity in the prevalence of counterfeit drugs at the retail level, though many within the country believe Uttar Pradesh, Bihar, New Delhi and Haryana to be the centres for manufacture and distribution of counterfeit and spurious drugs.
Drug controller general of India (DCGI) M. Venkateswarlu, who has studied the survey report, said it supports the view of the ministry of health and family welfare. “Even if we assume all the 3% they are suspecting to be counterfeit are proved so, it is still far less than the figures doing the rounds right now,” he said.
The estimates have varied widely from a low of 0.5% to a high 30% of the drugs sold in the country. According to WHO, although precise and detailed data on counterfeit medicines is difficult to obtain, estimates of counterfeit prevalence range from around 1% of sales in developed countries to more than 10% in the developing world.
Some in the drug industry questioned the study. “The findings seem inaccurate,” said a senior executive of a Mumbai drug firm who didn’t want to be named because he hadn’t personally reviewed the study. Still, “a sample size of 10,000 is too small for a country like India and checking only at the retail level (is) too restrictive”, he said.
Meanwhile, FIP’s vice-president in India, Prafull D. Sheth, declined to share the report or provide any details. But an industry insider familiar with the survey said some 400 retail chemists were part of the exercise, with clinical research company Apothecaries Ltd based in New Delhi, examining the samples in its laboratories.
This study, however, does not cover drug batches being exported from India or being disbursed through public or private hospitals. Countries in Europe and Africa have complained that spurious drugs manufactured in India have found their way into their home markets.
DCGI, meanwhile, is awaiting the final nod from the government to undertake a countrywide survey that could investigate up to 100,000 samples focused on a lot fewer brands than the FIP study’s 56.
In a recent interview with Mint, Venkateswarlu said the department is speaking to statistical organizations such as the Indian Statistical Institute to aid in this exercise. “It has to be a time bound, high-speed process. It’ll not just give a reliable estimate of the extent of the counterfeit drugs, but also help (us) in undertaking consequential action,” he said.
FIP is a body that represents national pharmaceutical (professional and scientific)associations, founded in The Hague in 1912.