New Delhi: India’s drugs quality regulator is readying a survey to map the prevalence of counterfeit drugs in the country with a smaller sample size but with a wider range of product categories compared with an earlier proposal for such a study.
The survey, in its new form, will pick up 31,000 samples of 62 top-selling medicines across nine therapeutic categories and will cover products of 29 manufacturers. The samples will cut across medicines administered for cardiovascular ailments, pain, infections, tuberculosis and even steroids, putting a diversified basket of drugs under the scanner.
This is in marked contrast to the way the study was originally fashioned under M. Venkateswarlu, the previous drug controller general of India, or DCGI, who retired on 30 January. That plan was to cover 50,000 samples each of five-six large volume brands, making for a sample size of up to 300,000 medicines. The aim then was to restrict the number of brands but cast the net deep.
The premise of the new survey, redesigned by the office of the current DCGI, Surinder Singh, is to cover the drug market as widely as possible.
The first-of-its-kind survey is expected to throw up a robust official estimate of the prevalence of spurious and fake drugs in the country. Current estimates put the prevalence between 0.5% and 30% of all the Rs34,000 crore-worth drugs sold in India. Countries in Europe and Africa have complained of Indian exports of counterfeit drugs into their markets.
“We have developed the study design with the help of Indian Statistical Institute (in Hyderabad) to ensure the results from the current sample size are statistically significant. Once we have the data, we will know where we stand,” said DCGI Singh, who expects a realistic estimate to emerge from the survey. The survey would not only give clarity on the true extent of menace in the country but also help India face up to international criticism “from a position of strength”, said Singh.
A senior official in the DCGI’s office, who preferred anonymity, said the survey would also help identify “geographical pockets” where the problem of fake drugs is rampant.
“We will collect two strips of each drug. One will be retained with us and the other sent to the drug makers. The companies will have to give in writing if the sample is original, made by them or not. If not, we will call it counterfeit,” said the official, explaining the methodology of the proposed survey. The other strip with the drug authorities could then be used for laboratory testing to check the quality of the drug.
The survey would be launched as soon as the financial grant of Rs50 lakh is sanctioned. Amendments to the Drugs and Cosmetics Act, 1940, are being finalized by the Union ministry of health and family welfare, as part of legislation that will levy hefty fines and punishment up to life imprisonment for offenders caught in the fake drugs trade.
An expert warned that while spreading out was a vital survey component, the sampling should cover rural areas, pockets of which are notorious for such activities and include medicine godowns as well. “The surveyors should definitely take as many samples as possible from the dealers (and) localities that have been identified as being notorious over the years. The pharmacies in rural areas and resettlement colonies are another important link,” said P.N. Bhargava at the drug anti-counterfeiting cell of Indian Pharmaceutical Alliance, an industry lobby. “In fact, large-scale godowns should also be in the survey as a lot of counterfeit drugs find their way into the system and are transacted in at that point.”
A study funded by the World Health Organization and carried out by global policy think tank International Pharmaceutical Federation found 3.1% of the more than 10,000 samples of 56 top-selling brands that it picked up to be counterfeit.