The Hindu : What to do about spurious drugs

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Friday, Dec 12, 2003

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What to do about spurious drugs

THE MASHELKAR COMMITTEE'S recommendations to check the proliferation of counterfeit and substandard drugs dovetail with the Government's pharmaceutical policy that was unfurled in 2002. But implementing its proposals will require a real demonstration of political will. Without this, the declared objective of making only quality drugs available in the market will remain a pipe dream. Foremost among the recommendations of the Committee is the creation of a centralised licensing authority for pharmaceutical products modelled on what is in place in the United States and some other developed countries. It notes that the multiplicity of licensing authorities spread across States has resulted in weak and non-uniform procedures. Delhi, Punjab, Haryana, Himachal Pradesh, Uttar Pradesh and Bihar are the States where spurious drug units are concentrated. By contrast, more than 75 per cent of licensed manufacturing takes place in Maharashtra, Gujarat, Tamil Nadu, Andhra Pradesh, Karnataka and West Bengal. Thus the rationale for vesting overall licensing powers in the proposed Central Drug Administration appears to be the need to break the nexus between drug manufacturers and officials at the State level. While such an arrangement will go some way towards curbing malpractices, from the point of view of the pharmaceutical industry it is important to avoid the pitfalls of an overcentralised system. Another recommendation of the Committee is the much overdue certification and classification of food, diet and health supplements or products that use Indian Systems of Medicine such as Ayurveda, Siddha and Unani. Considering that these products are not put through animal or human testing prior to circulation in the market, it is time that specification of the active ingredients contained in them was made mandatory by a designated authority.

The Mashelkar Committee cites the lack of adequate manpower in the States as a major factor behind poor enforcement of inspection, investigation and monitoring procedures both at the manufacturing and retail ends. It points out that currently there are only 950 drug inspectors to monitor 19,000 certified manufacturing licensees and over 400,000 sales licensees. It is imperative that the Government initiates swift action on such a critical recommendation if its intention of tackling the menace of spurious drugs is to carry some credibility with the pharmaceutical industry as well as the general public. Disturbingly, the share of counterfeit manufacture of drugs is estimated to be more than 10 per cent of the annual turnover of India's pharmaceutical industry, which is valued at Rs.20,000 crores. The adverse impact on public health as well as the economic implications of the malpractices may well be imagined. It is another question whether a State that is steadily withdrawing from core areas such as public health can summon the will to commit the resources needed to ensure effective monitoring and enforcement of drug laws.

However, one proposal of the Committee that is retrogressive is the recommendation that the maximum penalty for drug-related offences be raised from life imprisonment to capital punishment. In 1982, the Drugs and Cosmetics Act, 1940 was amended to enhance punishment to a life sentence. The truth is that despite a proliferation of spurious drugs in the market, penal provisions are rarely invoked against big players in the fake drug trade. Considering this iniquitous situation, what is needed is close and honest scrutiny of the enforcement record rather than resort to extreme, inhumane solutions. An impartial and fast-moving machinery imbued with functional autonomy is of paramount importance to track, investigate and punish criminal practices. This also commends itself from the standpoint of greater adherence to the rule of law and respect for human rights. Parliament should abort any attempt to prescribe the death penalty for offences related to drugs and work on the more sober and responsible recommendations offered by the Mashelkar Committee.

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