The Centre’s reported move to usher in a uniform drug licensing regime all over the country is just what the doctor ordered. A government expert panel recently emphasised the need for uniform implementation of documentation and dossier-based approval processes to ensure consistent drug quality and safety. A fragmented regulatory regime has clearly not worked, as is evident from the persistent issues of drug quality and efficacy.
There are 37 nodal agencies across states and Union Territories under the Central Drugs Standard Control Organisation (CDSCO) umbrella. The federal nature of drug regulations have, unfortunately, led to several states opting for regulatory forbearance in the name of ease of doing business. In 2020, drugs made by a Himachal Pradesh-based manufacturer killed 12 children in neighbouring Jammu & Kashmir—even though the products were flagged at least 19 times by various government drug laboratories. This is quite telling of the cost of siloed drug regulation in the country.Punitive powers of the drug licence issuing authority are exercised in widely varying ways. Ranbaxy whistleblower and drug safety advocate Dinesh Thakur points out, based on data from the Karnataka Drugs Control Department, that there is no uniformity among states on the length for which an erring manufacturer’s licence should be suspended.
While Himachal Pradesh opted for a 15-90 days licence suspension over the period that Thakur’s data covers, Uttarakhand suspended licences for a mere 20 days and Gujarat for just 1 day. Even these token penalties are not enforced properly—evident from zero legal challenge against the orders by the affected manufacturers. If production was actually suspended, at least some drug manufacturers would have exercised the legal option available to them under the Drugs and Cosmetics Act. There is little coordination among state regulators, as a result of which a drug manufactured in one state and identified as not of standard quality can freely be sold in another state.
To that end, a consolidated database of drugs—something that many experts argue could deal with the asymmetry of information regarding poor quality drugs—is a good practice. Unfortunately, it remains only on paper. The fact is that such a system would still be dependent on each state regulator updating details in a timely manner. Thus, a uniform approach that harmonises manufacturing standards, processes, and procedures of regulation is necessary. Indeed, centralised regulation and licensing have been a long-standing demand since the days of the Mashelkar Committee in 2003.A uniform system may be a bitter pill for those states that have attracted massive pharma investment with seemingly lenient regulations.
There will therefore be opposition to any such proposal on the grounds of an attack on federalism. Such moves must be resisted. The fact is that we are suffering, both as one of the largest consumers of medicines in the world and as the so-called pharmacy to the world, from poor drug regulation. Cough syrups made in the country were allegedly linked to the deaths of children in Gambia and Uzbekistan. This wasn’t a surprise as the US Food and Drugs Administration raised 21 Official Action Indications for Indian drugs, which means failure to comply with its standards, between 2019 and 2023 so far. The Centre has made a fair beginning by mandating phase-wise compliance with the WHO’s Good Manufacturing Practices for manufacturers. It now needs to follow it up with a common drug licensing regime.