New Delhi: The health ministry is expected to clear a proposal from the drug regulator to map the spread of fake drugs by collecting 50,000 drug samples from across the country, according to a person familiar with the matter.
The person, who did not wish to be identified because the proposal is with the ministry, added that this could happen within the next two weeks.
The proposal, from the office of the Drug Controller General of India (DCGI), has the support of the Organization of Pharmaceutical Producers of India, an industry lobby that represents all international drug makers in India, and the Indian Drug Manufacturers’ Association, the domestic manufacturers’ lobby.
“The funds for the survey could either come from the government or the World Bank. We might even ask the industry to contribute something,” said M. Venkateswarlu, DCGI.
Venkateswarlu is currently holding discussions with statisticians and research firms to arrive at a sample size that is statistically significant or will present an accurate picture. The survey may cost between Rs2 crore and Rs3 crore.
Mint had first reported DCGI’s proposal to conduct a survey on 18 July. “If there is as much wrong with the sector as is made out to be, then it has to be set straight, but first we need a true picture of the menace,” Venkateswarlu had said then.
Estimates of the prevalence of fake drugs vary widely—from 0.5% to 30% of the Rs55,000 crore of drugs sold in India each year.
In a series of articles this year that looked at lax regulation of drug manufacturing and drug trials in India, Mint had highlighted the ease with which fake drugs can be obtained, as well as delays and inaction on the part of regulators in dealing with the issue. A 2005 Bill to tighten regulations has been waiting for parliamentary clearance.
In response, DCGI has proposed random checks of laboratories that do human drug trials in India.
Earlier in July, Union health minister A. Ramadosstold Mint that he will introduce a new Bill in the monsoon session of Parliament, proposing severe penalties for makers and sellers of spurious drugs.