The Drugs Controller General of India (DCGI) should make quick efforts to define ‘counterfeit’ drugs according to the World Health Organization (WHO) norms. Currently, there is no definition for counterfeit drugs as far as India is concerned. But there is a big hue and cry about the circulation of counterfeit medicines without authenticated documents in the country, according to Dr BR Jagashetty, Karnataka Drugs Controller.

There is both concern from consumers and panic by the pharma industry on the allegation of counterfeit drugs produced or circulated in India. However, the Drugs & Cosmetics Act only carries definitions of spurious, misbranded and adulterated drugs under Section 17 for the domestic market and Section 9 for imports.

It has been reported that in a survey carried out by the Central Drugs Standard Control Organization (CDSCO) last year, prevalence of spurious drugs sold across pharmacy outlets in the country was estimated at 0.046 percent. But in a study by WHO undertaken by the International Pharmaceutical Federation, 3.1 per cent of drugs from India were counterfeit based on packaging and fake contents.

“Such information is misleading. Therefore, it should be the prerogative of the DCGI to vehemently prevent use of the word ‘counterfeit’ in the context of drug quality,” he added.

According to the Karnataka drugs controller, factors which encourage the spurious drugs are weak legislation and regulation, lack of cooperation or coordination with regulators between Centre and states or two states, prevalence of corruption and difference of interest. There could also be commercial gain on the part of pharma manufacturers and high cost of drugs that could make companies and distributors to be associated with products of poor quality.

There are several questions posed before regulators on the definition of counterfeit drugs and its presence in the market. These include: Whether substandard drugs could come under counterfeit category; availability of good quality counterfeit drugs; whether counterfeit drugs are a big problem and what varieties of drugs are counterfeit; etc. Further there are also queries on the kind of efforts needed to ensure high quality, safe and efficacious drugs in the market and on the possibility of a licensed pharma manufacturer producing substandard and counterfeit drugs, etc, he stated.

In order to put things in perspective, Karnataka drugs control department is working towards setting up a Committee which will have representatives from pharma industry, trade and consumers to be actively involved in controlling the presence of spurious drugs, said Dr Jagashetty.