Editorial: Short of expectations

The Jan Vishwas Bill, 2023, passed by the Lok Sabha recently fails to allay safety concerns

India’s hard-earned image as a global drugs manufacturing hub took a major hit recently, with the twin tragedies in Gambia and Uzbekistan where the death of nearly 90 children was linked to adulterated cough syrup manufactured by Indian pharma companies. The deeply embarrassing developments raised questions over the efficacy of the country’s regulatory mechanism and prompted calls for a systemic overhaul. The Jan Vishwas Bill, 2023, passed by the Lok Sabha recently, is an attempt to promote ease of doing business and reduce the compliance burden for the pharma industry but it has failed to allay the safety concerns. What is more disquieting is that the proposed amendments will reduce punishments for manufacturers of medicines that are not of standard quality. The new legislation may end up benefiting big businesses. The Bill proposes to decriminalise 183 provisions in 42 legislations, including over half a dozen colonial-era laws. It proposes to decriminalise certain offences and rationalise punishment, doing away with provisions of imprisonment or converting some fines to penalties that do not necessitate prosecution. The government insists that the drugs Act’s Section 27D would continue to have the criminal provision of punishment of one to two years. However, the option of compounding does open a window for evading a jail term by paying up. The changes to the original legislation governing the manufacture, storage and sale of medicines put a question mark on drug regulation efforts.

It is widely feared that the provision of paying a fine rather than facing imprisonment and the scope for an out-of-court settlement would undermine the fight against substandard drugs. There is a worry that this could well result in the manufacturers getting off lightly. There is a need to dispel misgivings that the move is anti-consumer and would benefit big businesses. The government must at least agree to a wider debate in the Rajya Sabha. The measures contained in the latest Bill are not enough to revitalise the pharma sector. There is a need for a common set of standards and regulations across all the States. India does not have a consolidated public database that records the transgressions of each company licensed under the Drugs And Cosmetics Act. At present, there are 38 drug regulators — one for each State and union Territory, in addition to the national regulator Central Drug Standard Control Organisation (CDSCO). Each of them has its own network of laboratories, inspectors and jurisdiction. As a result, they operate in silos, making the whole system opaque. Under the present setup, if violations are found in the functioning of a drug company in a State, such information will not be shared with the drug regulators of other States or with the CDSCO. This renders the regulatory mechanism ineffective. For a country whose pharmaceutical industry has a larger global profile, this is not a desirable situation.

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