To curb the menace of spurious and sub-standard drugs and address the non-conformity of quality standards among diagnostic centres across the country, the office of principal scientific advisor to the Prime Minister has constituted a working group committee. The mandate of the committee is to recommend in next nine months time, scientific and technological measures that can be implemented to reduce the incidence of spurious and sub-standard drugs.
The committee that was formally put in place recently has started functioning with the first meeting, taking place at the end of December 2008. The PSA working group, chaired by PN Tandon, professor emeritus, All India Institute of Medical Sciences has representation from the medical fraternity, Drug Controller General of India, medical journal, industry and consumer rights organisation apart from representative of PSA?s office. The purview of the new committee includes studying the prevailing and planned international practices adopted world wide to tackle the evil of spurious drugs, particularly in case of regulated markets like the United States of America and other countries in Europe. The expert group will also analyse the status of the problem in the country and then suggest specific scientific measures that can be taken up to address the social evil.
Asked if the scope of the committee will overlap and clash with that of Mashelkar Committee, a member said, ?On the contrary it should complement the earlier recommendation. While Mashelkar recommendation focused on tightening of regulatory framework and making the penalties of guilty drug manufacturers stringent, the purview of the current working group is to concentrate on strictly scientific measures and R&D steps that can bring down the incidences of spurious and sub-standard drugs?.
In 2003, the government had constituted a committee under the chairmanship of RA Mashelkar, former director general, CSIR to comprehensively examine the issue of spurious drugs. The committee that submitted its report in December 2006 had suggested that penalties for such spurious drugmakers be made more stringent apart from other measures like setting up of special courts for speedy trials and making the offences relating to spurious drugs non-bailable. Last July, the Cabinet gave its nod to move official amendments to Drug and Cosmetic Amendment Bill, 2005 that prescribes an imprisonment for a term for not less than 10 years which may be extended to life term and fine of not less than Rs 10 lakh or three times value of the drugs confiscated, whichever is more, for a person involved in the manufacture and sale of spurious drugs.
Owing to the nature of the work, there are no authentic sources that provide accurate statistics on the magnitude of the problem of spurious drugs. Although there is no consensus, various estimates put the counterfeit drug industry ranging from 0.25% to 25% of the overall pharma industry size. According to a the World Health Organization update of 2007, one in five medications sold in India?s major cities is fake. The pharma industry claims an annual revenue loss between 4-5% due to fake drugs. The industry also estimates that spurious drugs have grown from 10% to 20% of the total market. According to government of India latest estimate, the size of the pharma industry is estimated at more than Rs 60,000 crore growing at 10-15%, annually. Periodical industry estimates released also point towards a similar trend. Sale of fake and spurious drugs in the National Capital Region is estimated to be Rs 300 crore annually, which constitutes 20-25% of the total medicines sold in the region, a recent Associated Chambers of Commerce and Industry of India survey indicated. Sales of counterfeit drugs worldwide are estimated at $32 billion, causing $46 billion annual loss to the global pharmaceutical industry, according to recent reports.
The WHO defines a counterfeit medicine as ?one which is deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging.?
The other issue that the committee is addressing is that of diagnostic labs. Of the one lakh plus diagnostic and path labs in the country, less than one thousand have quality accreditation. Since most of the medical labs have registered under the Shops & Establishments Act and not under the Clinical Establishment, their accountability is no more than that of a grocery store or barbershop for the services they provide to their customers.
Right prescription
• One in five medications sold is fake, WHO 2007 update
• Spurious drugs have grown from 10% to 20%
• Of the one lakh plus diagnostic and path labs, less than 1,000 have quality accreditation
• Studying prevailing & planned international practices adopted world wide to tackle the evil of spurious drugs