The Government’s study on spurious drugs in the country is set to gain momentum in the next few months, a senior Government official said.
The Central Drugs Standard Control Organisation (CDSCO) in consultation with the Indian Statistical Institute and other partners, including the State drug controllers, have put in the basic framework on how to carry out the study, including details on the category or medicines to be covered, said Bangarurajan, Deputy Drugs Controller, CDSCO (West Zone).
With the basic framework in place, the study will be rolled out in terms of actually picking up samples from across the country and analysing them before coming out with a final report, he said, speaking on the sidelines of a pharmaceutical industry event organised by the Indian Drug Manufacturers’ Association. About 15 categories of medicines, such as anti-malarials and antibiotics, have been identified to be surveyed, he added.
Former Drug Controller-General of India, Surinder Singh, who is now Director of the National Institute of Biologicals, heads this committee that is studying the prevalence of spurious drugs.
The study gains in significance against the backdrop of quality questions being raised on Indian medicines by overseas regulators. The Indian drug regulatory representative, however, added that local authorities were also keeping an eye on local pharmaceutical products and their quality has been improving over the years.
A similar study on spurious drugs was conducted in 2009, where 24,000 samples were picked up from across the country. The prevalence of spurious products was found to be about 0.04 per cent, he said.
Various numbers are discussed when it comes to the prevalence of spurious drugs in India, including numbers attributed to the World Health Organisation, that have in fact been denied by the WHO, he said.
Meanwhile, the Government is also expanding the number of Adverse Drug Reaction (ADR) centres in the country to record incidents of reactions related to medicines. From about 150 now, it would go up to over 380 by 2015, he said, adding that all Government medical colleges would have an ADR centre. This expansion comes even as the Government doubles its drug regulatory personnel from about 1,500 at present.
The drug regulator is already collaborating with foreign regulators during inspections of local drug plants, he said, on the steps being taken by India to harmonise its drug regulations with international laws.
At a recent conference on drug regulations in Brazil, he said, regulators were concerned with the uniformity of Good Manufacturing Practices norms across different countries. The thinking was on whether inspections done by one regulator could be picked up by others to avoid multiple inspections, he said.
On harmonisation of regulations across countries, Ronald Piervincenzi, Chief Executive Officer of the US Pharmacopeia, said it would benefit industry as it makes them more efficient with a single approach on quality standards across markets, even as it eliminates multiple testing.