Govt embarks on largest ever survey of spurious, sub-standard drugs

Aditi Tandon

Tribune News Service

New Delhi, January 18

Amid concerns around the quality of medicines being manufactured in India for domestic use and export, the government has embarked on the largest ever survey of spurious and substandard drug formulations to assess the exact scale of the problem.
Health Ministry through the Central Drug Standards Control Organization (CDSCO), the country’s apex drug regulator, and the National Institute of Biologicals, Noida, will test over 42,000 samples of a range of drugs to judge their quality. Rs 10 crore are being spent on the mammoth exercise to be completed by July.
Drug Controller General of India GN Singh today told The Tribune that the survey is meant to develop scientific evidence regarding the quality of India drugs in the wake of fears around their safety not just for domestic use but also exports.
“Our surveys over the past decade have found the prevalence of spurious drugs at not more than 0.04 per cent and that of sub standard medicines at not more than 4 to 5 per cent. Yet, there is no let up in reports that India is exporting sub standard drugs. We need to bust this myth besides reassuring ourselves of the quality of our drug formulations,” GN Singh said.
The last national survey of spurious drugs in 2009 tested 24, 136 samples and concluded, “The extent of spurious drugs in retail pharmacies of India is much below the projections made by various media, WHO, SEARO, and other studies. It is 0.046 per cent — 11 samples out of 24,136 samples tested.”
The 2009 survey tested the following categories of drugs —- anti-infective; steroids; antihistaminic; cardiovascular; anti-diabetics; anti-malarial; anti-TB and multivitamin preparations.
This time the government will also test combination drugs for the first time. Already, conscious of irrational fixed dose combinations being marketed, the DCGI is reviewing 6000 applications from manufacturers of fixed dose combinations in India. “All FDCs in Indian markets are under review. We will weed irrational ones soon,” GN Singh said.
The government’s largest drug survey comes close on the heels of certain countries expressing concerns at international about the quality of exported drugs from India. India’s pharma industry is the world’s fourth largest in volume and exports to 200 countries with a projected growth rate of 14% a year.
The Ministry of Commerce had last year issued a statement rejecting accusations that India was exporting counterfeit (spurious drugs) saying these accusations were desperate attempts to malign India’s fast growing pharma sector which produces low cost, high quality drugs.
But the government has now decided to test its claims scientifically to strengthen and safeguard its drug export market potential from what it believes to be “unsubstantiated claims”.