New Delhi: The largest ever nationwide survey of its type conducted by the ministry of health and family welfare shows that the extent of fake drugs sold in pharmacies across the country has been hugely overestimated.
The survey results, which have left pharmaceutical companies unhappy, come as a relief to the government even as it has struggled to remove the stigma of India being the fake medicines hub of the world.
The government has over the past 11 months taken sustained steps to crack down on the manufacture and sale of fake drugs in the country. Indians buy Rs50,000 crore worth of medicines each year. The country produces medicines worth Rs85,000 crore, of which exports are worth Rs35,000 crore.
The survey was conducted by the Central Drugs Standard Control Organization (CDSCO). It found the prevalence of spurious drugs at 0.046% of all medicines sold to customers. An earlier survey of 10,000 samples, funded by the World Health Organization and undertaken by the International Pharmaceutical Federation, had concluded that 3.1% of drugs in India were counterfeit—so defined even if the packing and not the ingredients of the drug was fake.
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This survey, based on a model provided by the Indian Statistical Institute, involved the collection of 24,136 samples of medicines, less than the original target of 30,000. Samples of 61 popular brands of oral, solid dosage formulations belonging to nine therapeutic categories (anti-infective, anti-malarial, anti-tuberculosis, steroids, antihistamines, cardiovascular drugs, anti-diabetes, non-steroidal anti-inflammatory drugs and multivitamins) were collected from each zone of CDSCO with the help of non-governmental organizations and consumer associations.
According to the executive summary of the final report that has been sent to the ministry, a copy of which was reviewed by Mint, the collected samples were handed over to the respective manufacturers for physical examination. Once the manufacturer approved the product as genuine, they were sent to the government’s own testing laboratories as well as one private laboratory. Around 15% of these samples were then randomly selected and tested further.
The summary also shows that the 11 samples that were not accepted as genuine products by their manufacturers were from Bihar, West Bengal, Uttar Pradesh and Gujarat.
However, the survey’s methodology has attracted criticism.
“We don’t agree with the survey. It lacked public-private partnership. The government worked in isolation and did not take our assistance in finding fake drug manufacturers,” said Harinder Sikka, director (corporate affairs) at Piramal Healthcare Ltd. He added that with its active field force that is meant to keep track of fake and substandard drugs, the industry could have helped the regulator trace such drugs and suggest a better method to collect samples.
The idea and model of the survey was mooted in 2007 by the then Drugs Controller General of India (DCGI), who had proposed to collect 50,000 samples. This was later reduced to 30,000 by the current DCGI, Surinder Singh.
Earlier this month the Centre had firmed up guidelines for its whistle-blower scheme, aimed at rewarding those who alert government agencies about firms and individuals manufacturing and selling fake drugs and cosmetics.
“After the whistle-blower scheme, we have raided many places,” said Singh. Officials of CDSCO recently raided Bhagirath Palace in Delhi and dawamandis (medicine markets) in Kanpur, Agra and Moradabad in Uttar Pradesh, he said. In Mumbai, drugs have been seized from two places. “We have taken samples and sent them for analysis to the labs.”
The health ministry will soon also include the guidelines for spurious drugs in the Drugs and Cosmetics Act in order to make them statutory. In August, the health ministry notified and implemented the Drugs and Cosmetics (Amendment) Act, 2008, significantly increasing the penalty for the manufacture of spurious or adulterated drugs.
As an additional step, CDSCO has also decided to re-examine the definition of spurious, adulterated and misbranded drugs. The Drugs and Cosmetics Act will approach the review of the definition from two angles. One, the industry is not harassed. Two, intellectual property right (IPR) issues are not involved.
“Wherever IPR issues can be interpreted…that part we will take out. We have made a brief on this and will form a committee to sit and look at the definition and bring it in line,” said Singh.
Graphics by Sandeep Bhatnagar / Mint