Regulatory reform stuck in a loop in Health Ministry Premium

The Drugs Controller General of India’s recent policy initiatives either lack the force of law or are poorly thought through

Earlier this year, the Drugs Controller General of India (DCGI), working under the direct control of the Ministry of Health and Family Welfare, announced policy initiatives on three issues: recall guidelines, guidelines on good distribution practices and the use of similar brand-names by pharmaceutical companies for their drugs.

All three measures have a direct impact on public health. Recall guidelines are meant to swiftly remove drugs that fail testing in government laboratories from the market. The guidelines on good distribution practices are meant to regulate how drugs are stored and distributed during transit and sale. The measure against confusing brand names is aimed at preventing prescription errors, wherein wrong drugs are dispensed to patients causing them harm.

Unfortunately, these measures either lack the force of law or are poorly thought through. For over a decade, we have seen this old wine of vague guidelines and cautionary letters sold to us in a new bottle, disguised as concrete measures of reform.

A good starting point for this discussion is the 59th report of the Department Related Parliamentary Standing Committee on Health & Family Welfare (PSC) which was tabled in 2012. In this report, which focused on how the national drug regulator, the Central Drugs Standard Control Organisation (CDSCO) functions, the PSC raised a host of issues including the lack of recall guidelines, the lack of standards for storage of drugs and the problem of confusing brand drug names.

These issues were flagged decades before the PSC examined them in its 59th report. The lack of recall guidelines was flagged during a meeting of the Drugs Consultative Committee (DCC) back in 1976 when State drug controllers realised that drugs ordered to be withdrawn in one State due to quality concerns were being sold in a neighbouring state. The lack of proper standards for storage of drugs, especially during transportation, was flagged by the Supreme Court of India in 1974, in Swantraj & Ors vs State Of Maharashtra. Similarly, the issue of similar brand names for different drugs was flagged by the Court in 2001 in Cadila Healthcare Limited vs Cadila Pharmaceuticals Limited.

When the PSC raised these very issues in its 59th report, it created significant pressure on the Ministry of Health because it demanded follow-up action. The PSC even published a scathing “Action Taken Report” the following year indicating its unhappiness with the lack of effective reform by the Ministry of Health. Unfortunately, these issues raised by the PSC over a decade ago are yet to be tackled effectively and have been stuck in a loop at the Ministry of Health, since the bureaucracy is either unable or unwilling to tackle these issues.

For example, the most recent drug recall guidelines announced in August by the DCGI were in fact first announced in the year 2012 after the PSC report was tabled and then again in 2017. In all three instances, the initiative for drug recall guidelines came from the office of the DCGI, except that the DCGI lacks the legal power to make rules that are binding and have the force of law. Only the Ministry of Health has that power under the Constitution. As a result, 48 years after the lack of recall guidelines was first identified at the DCC, India continues to have these guidelines which cannot be legally enforced and the breach of which have no legal consequences. It is no wonder then that we never hear of action removing ‘not of standard quality drugs’ from the market.