‘Vague guidelines and cautionary letters have been issued disguised as concrete measures of reform’
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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.
The 59th report of the PSC
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of the Drugs Consultative Committee (DCC) back in 1976 when State drug controllers realised that drugs ordered to be withdrawn in one State due to quality concerns were being sold in a neighbouring state.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.
Non-binding guidelines in a loop
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.
The story with the guidelines to regulate the storage of drugs during transit and sale is even more depressing. After the PSC report, a proposal to adopt good distribution practices guidelines formulated by the World Health Organization (WHO) came up for discussion at the meeting of the DCC in 2013. The proposal at that time was to make good distribution practices guidelines legally binding. However, this proposal was opposed within the DCC because it was felt that it would be too “difficult to implement” across the estimated six lakh retail outlets in the country — the DCC likely anticipated pushback from trade associations of pharmacies since the good distribution practices guidelines would require investments in storage equipment. This reluctance to make good distribution practices guidelines mandatory was a dereliction of duty toward public health because India is a hot and humid country. In many parts of India, especially during summer, drugs are guaranteed to degrade without proper temperature and humidity controls. In 2019, the GDP guidelines were back on the DCC’s agenda after a raid at the wholesale market for medicine at Bhagirath Palace, New Delhi revealed shockingly poor storage practices for drugs, including vaccines. This time though, the DCC resolved to make good distribution practices guidelines into binding law. The matter came up again at a meeting of the DCC earlier this year where the government has admitted that the lack of the binding nature of the GDP guidelines was a problem. However, instead of proceeding to declare the guidelines as binding law, the government has once again decided to conduct another round of consultation with stakeholders, thereby further delaying the implementation of WHO standards.
The story with confusing brand names follows a similar trajectory. Despite being flagged by the top court in 2001 and the Parliamentary Standing Committee in 2012, the government did nothing to fix the problem. After receiving a rap on its knuckles from the Delhi High Court in 2019, the government introduced an entirely useless legal rule to address this issue. Instead of creating an obligation upon the regulator to vet the brand names before a drug could be marketed, the Ministry created a rule requiring pharmaceutical companies to provide a self-declaration that their proposed brand name was not similar to any of the existing brand names in the market. In most other countries, it is the duty of the regulator to vet the brand name, to ensure that it is not confusing or misleading from a public health perspective. It makes no sense to ask the pharmaceutical industry to self-regulate on this issue as evidenced by the large number of confusing pharma brand names in India even after these rules came into force. Earlier this year, after we wrote about the issue in this daily, the National Human Rights Commission (NHRC) intervened and issued notice to the Ministry of Health. In response, the Directorate General of Health Services (DGHS) wrote a letter to the Registrar of Trademarks asking to ensure that confusing trademarks were not registered. The DGHS completely misses the point that trademark registration is voluntary. Many companies do not seek to register their brand names as a trademark. Even when trademark applications are filed, the Registrar of Trade Marks conducts a perfunctory “confusion analysis” that does not include a public health perspective. Brand names should ideally be scrutinised by the regulator for being misleading and fanciful from a health perspective.
Breaking the loop
The three reform measures discussed here are reflective of a consistent leadership failure in the higher echelons of the Ministry of Health. Matters pertaining to drug regulation are meant to be guided by a joint secretary heading the Drug Regulation Section in the Ministry. This officer, who usually hails from the All India Services, holds the post for a few years before moving on to the next posting. She has little domain expertise in this area and lacks the institutional knowledge that policymaking requires. We suspect that with every newly appointed joint secretary, these files go through with repeated consultations with stakeholders in the pharmaceutical industry. In each of these consultations, the trade associations of pharmacies and pharmaceutical companies use every trick in the book to stall the necessary action and the bureaucracy uses a familiar playbook of repeat consultations to stall concrete action. We doubt that the loop will be broken without the direct intervention of the Prime Minister’s Office.
Dinesh S. Thakur is the co-author of ‘The Truth Pill: The Myth of Drug Regulation in India’ (2022). Prashant Reddy T. is the co-author of ‘The Truth Pill: The Myth of Drug Regulation in India’ (2022)
Published – September 10, 2024 12:16 am IST
