If the official statistics is to be believed, there has not been a single proven instance of spurious drug detection in 15 states of the country during the last three years. Spurious medicine was found just once in other three states during the period. According to the figures brought out by the Union Health Ministry in response to queries from more than two dozen Members of the Parliament (MPs) during the ongoing session, the continued presence of spurious drugs were reported from just 10 states.
The official revelation has thrown up more questions than answers as the statistics has given space to both drug regulatory authorities as well as major pharmaceutical companies to support their views on spurious drug issue. While the drug regulatory authorities point out that the meager or no cases of spurious drug detections from majority of the states are proof of the limited presence of the clandestine activitiy, the industry sees it as proof of the ineffective regulatory system, that has failed to detect the presence of spurious drugs.
Among the 32 states/UTs (barring Uttaranchal, Chattisgarh and Jharkand) figured in the list, Arunachal Pradesh, Goa, Kerala, Manipur, Meghalaya, Mizoram, Nagaland, Sikkim, Tripura, Pondicherry, Andaman & Nicobar Islands, Chandigarh, Dadra & Nagar Haveli, Daman & Diu and Lakshadweep are the 'spurious drug free' areas. Though there were no cases of spurious drug detection in the previous two years, Orissa and Himachal Pradesh had one case each in 2002-03. In Assam there was a recorded instance in 2001-02.
The total number of spurious drugs detected in the country during the period between 2000-03 is 337 (112 in 2000-01, 96 in 2001-02 and 129 in 2002-03). The recorded instances of spurious drugs in other states with yearwise break-up are Haryana 70 (15 + 42 + 13), Uttar Pradesh 52 (19 + 3 + 30), Rajasthan 40 (13 + 20 + 7), Punjab 37 (17 + 4 + 16), Andhra Pradesh 37 (27 + 4 + 6), Maharashtra 27 (3 + 3 + 21), Delhi 22 (7 + 5 + 10), Tamil Nadu 12 (4 + 0 + 8), Bihar 9 (3 + 3 + 3), Gujarat 9 (2 + 2 + 5), West Bengal 9 (1 + 2 + 6), Karnataka 5 (0 + 4 + 1), Madhya Pradesh 3 (1 + 2 + 0), and J&K 2 (0 + 1 + 1).
The officials pointed out that the north eastern states and the southern state of Kerala come under the same group for totally different reasons. "While northeast is known for its absence of proper drug regulatory system, the social milieu and the vigilant drug control machinery ensured the absence spurious drugs in the southern state", they explained.
Similarly, the active role of state drug administrations in certain states like AP, Maharashtra and Delhi helped in detecting more cases of spurious drugs whereas absence of such strict vigil was the reason for less cases in some other states, they added.
The government figures however, do not give an idea about the NSQs that were found in the country during the last three years.
The government figures have come at a time when industry and trade associations representing the interests of multinational and large domestic players in Indian pharmaceutical industry are vigourously campaigning against the growing menace of "spurious drugs in the country". The representatives of these associations have been quoting "WHO" figures, which, according to them, is giving India the notorieity of chruning out 35 per cent of the world's spurious drugs. If the industry associations' claims are to be taken seriously, Indian fake drugs market is estimated to be worth Rs 4,000 crore, about 20 per cent of the total drugs market. Interestingly, the associations' claims are based on their own market surveys, which are yet to be supported by any official study. The associations have also succeeded in generalizing the concept of spurious drugs without any specific mention on the percentage of copycat versions, not-of-standard-quality drugs and the like that are known to consistute a major share in the figures quoted by the associations.
The government had always been shying away from such generalization as the authorities stand for separate laws and rules to handle each of these issues. The recently constituted expert committee for undertaking a comprehensive review of the drugs regulatory system has spurious drug problem among its topmost agenda. The committee is known to have asked an independent agency to conduct a study to gauge the depth of the spurious drug issue.
It is to be seen how the expert committee under the chairmanship of Dr R A Mashelkar, would take up various issues that cause reduction in the potency of a drug, including the criminal act of manufacturing fake, spurious drugs with no therauptic value.