Magnitude of Spurious Drug Trade in India

There are several conflicting yet alarming reports about the extent of spurious medicines in Indian markets ranging from as low as 0.25%, as per govt. claims to a whopping 35% as claimed by several independent groups like ASSOCHAM, CII, OECD, EC etc. As per WHO reports spurious drugs now represent 10-12% of $735 billion global market of medicines. Sales of counterfeit drugs worldwide are estimated at $32 billion, causing $46 billion annual loss to the global pharmaceutical industry, recent reports have said. The New York based Centre for Medicines in the Public Interest has predicted that counterfeit drug sales will reach US$ 75 billion globally in 2010, an increase of more than 90% from 2005. Thus the problem of spurious drugs is reported to be a global phenomenon and India is no exception. India’s pharmaceutical companies have suggested that in Indian major cities, one in five medicines sold is a fake. They have claimed a loss in revenue of between 4% and 5% annually. The industry also estimated that illegal drugs had grown from 10% to 20% of the total market.

According to industry claims, 30 per cent of the Rs 22,000 crore pharma market in India is constituted by spurious products, which translates to an over Rs six-crore trade. About 40% of drug products tested for quality in Nigeria and found to be outside the British Pharmacopoeia limits for drug assay were actually manufactured in India. ASSOCHAM estimates that the lethal market is growing at 25% annually. In fact, the Organization for Economic Cooperation and Development's latest figures say 75% of fake drugs supplied the world over have their origins in India. A recent report by the European Commission said that India is the biggest source of counterfeit drugs in the world, followed by the United Arab Emirates, China and Switzerland. Together, these countries are responsible for more than 80% of all counterfeit medicines, the report said. The GOI, health ministry’s estimates are more conservative though: It says 5% of drugs in India are counterfeit while 0.3% are spurious. Based on the samples tested by the State drug testing authorities in India, for the period 1995-2003. the extent of sub-standard drugs varied from 8.19 to 10.64% and of spurious drugs varied between 0.24 % to 0.47%.

Even as the Health Ministry in India had not yet flagged off its ambitious study to ascertain the extent of spurious drugs in India, details of a recent WHO-sponsored study showed that only 0.3 per cent of samples were found spurious in lab tests, though over 3.1 per cent were found to be counterfeits during visual inspections. The study, held by SEARPharm Forum (South East Asian FIP-WHO Forum of Pharmaceutical Association) in collaboration with Delhi Pharmaceutical Trust, reported that the anti-infective category and those drugs priced below Rs 20 were most prone to counterfeiting. During visual inspection, the extent of counterfeit suspects was to the tune of 3.1 per cent. This was assumed due to striking registration differences in the packing. Based on the domestic sales of Rs. 31,500 crore (7 billion USD) in 2006, the extent of suspected counterfeit medicines would be extrapolated to approximately to Rs. 1000 crore (USD 250 million). These figures are considerably lower than Rs. 4000 crore (USD 1000 million) in earlier reports.

The data showed the Bihar has the highest probability of spurious suspects, with 5.65per cent of samples turning spurious. On a region basis, Central region had more counterfeit suspects. The extent of prevalence was 4.21 per cent while the West had 4per cent, East 3.2 per cent, North 3 per cent and South with 2.8 per cent. Sale of fake and spurious drugs in the NCR region to the extent of Rs.300 crore annually continues to be unabated as, according to the latest ASSOCHAM survey, it has gone upto 20-25% of the total medicines sold in the region. The concentration of fake drugs manufacturers can largely be found out in locations such as Bahadurgarh, Ghaziabad, Aligarh, Bhiwadi, Ballabhgarh, Sonepat, Hisar and Punjab. The analysis of suspected samples showed that even from the states perceived to be strongly regulated, the percentage of counterfeit suspects is almost same as weakly regulated. Confederation of Indian Industries (CII) has concluded that spurious drugs cause a revenue loss of over Rs. 4000 crore to the Indian Pharmaceutical Industry. They have further asserted that in 2001, out of a total production of Rs. 22, 887 crores, 18 % was spurious amounting to Rs. 4112 crores. They have revealed that a majority of medicines supplied under government orders fail necessary quality control tests.

Ex-Union minister for health and family welfare Anbumani Ramadoss is reported to have said in the Lok Sabha that the government of India has never conducted any study to find out the actual extent of spurious medicines in Indian markets. However, two pilot exercises have evaluated the extent of counterfeit drugs in India, one by the office of deputy drugs controller (DDC), Western Zone, and the other by an independent forum known as SEARPharm. A total of 3,246 samples were drawn in the combined exercise. The results of the samples tested revealed only five drugs as counterfeit and two samples not complying to the standards,Ramadoss said. The drive undertaken in two months by the western zone office of the Central Drug Standard Control Organisation (CDSCO) which tested 800 samples from various parts of the region, could find only one counterfeit drug, while it detected no spurious ones. This has been claimed by ex-Deputy Drugs Controller of India (West Zone) Dr. Venkateswarlu, who later on assumed charge as the Drugs Controller General of India. Samples in this study were collected from rural areas in Madhya Pradesh and Orissa. According to the Maharashtra Food and Drug Administration, spurious drug trade is only one per cent of the total marketed formulations in the state.

To ascertain the extent of counterfeit drugs produced in India, the government of India launched a pan-India survey a couple of years back. The move was expected to help the health ministry to collect an authentic data on the problem of fake medicines before taking action against the culprits. The ministry had initially aimed at collecting 3-4 lakh samples during the survey in which the volunteers were expected to pick drug samples from the medical stores even in remote places. However only 24780 samples were collected from across India during November-December, 2008. The drug samples were then sent to drug makers (who have procured the license to produce the packs) for verification, while the doubtful packs were sent for further investigation. In 2009, Union Ministry of Health and Family Welfare made the report of this survey public through Central Drug Standards Control Organization (CDSCO). Survey report revealed that the extent of spurious drugs in retail pharmacy is much below the projections made by various media, WHO, SEARO, and other studies i.e. only 0.046 %. Only 11 samples out of a total of 24,136 samples collected were found to be spurious and the extent of substandard drugs among the branded items is only 0.1 %. Out of a total of 2976 unsuspected samples, only 03 samples did not conform to claim with respect to Assay on chemical analysis.

In this survey a total of 24,780 samples were collected by visiting around 40,000 pharmacy outlets. Samples of popular brands of oral solid dosage (OSD) formulations, belonging to 9 therapeutic categories of anti-infective, anti-malarial, anti-T.B.Drugs, steroids, antihistaminic, cardiovascular drugs, anti-diabetics, NSAIDs, and multivitamin preparations, were collected between November & December 2008 from all across the country. It is not clear from the survey report published by the Central Drug Standards Control Organization (CDSCO) in 2009 as to how many samples were collected from the state of Jammu and Kashmir and which all districts of the state were included in the survey, though it is mentioned that a total of 5665 samples were collected from the entire North Zone including the state of J&K.

With most of the fake drug manufacturing units being based in neighbouring Punjab, Haryana and U.P, Jammu and Kashmir for its proximity to these states has been receiving a fair share of the drugs and medicines manufactured there. In the absence of any robust studies for estimating the magnitude of spurious drug trade on scientific lines in the state it is difficult to hazard a guess on the exact percentage of counterfeit medicines in the state and on the exact impact of such drugs on the health of people at large. There is need to conduct a comprehensive statewide survey on spurious drug trade wherein large number of samples need to be picked from every nook and corner of the state to arrive at a firm conclusion about the extent of the problem prevalent in our state. Further remedial measures suggested by the World Health Organization, IMPACT group, USFDA and Mashelkar Committee like Rapid Alert System (RAS) and Radiofrequency Identification Technique (RFID) need to be implemented in toto to put an early end to the problem.

At present drug inspectorate staff of this state have to spend most of their time in courts pleading for various prosecutions launched by them and are left with very little time to conduct probe against spurious drug rackets operating in their jurisdiction areas. There is urgent need to create separate intelligence and legal cells in the state as well as central offices with adequate provisions of secret funds and incentives for informers. In addition special courts need to be designated to exclusively try the cases of spurious drugs. Severe and deterrent punishments as afforded under law should be imposed on persons dealing with spurious drugs. Exemplary penalties need to be awarded to those found guilty of perpetrating such a heinous crime against humanity.