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Jan Vishwas Bill, Passed Recently, Further Weakens Regulation of Pharmacies, Say Critics

The legislation could dramatically increase the risk-taking behaviour of pharmacies to the detriment of public health in India, say experts.

New Delhi: The Jan Vishwas Bill, which was passed on July 27 by Lok Sabha and on August 2 by the Rajya Sabha, amid Opposition protests over Manipur violence, has once again sparked a debate among health policy experts and activists due to its “lenient approach” to the crime of manufacturing “not of standard quality” (NSQ) drugs, having an adverse impact on public health.

Several experts and activists feel that the Bill pays comparatively less attention to the adverse impact that the legislation would have on an equally serious issue, which is the regulation of pharmacies that have a key role to play in India’s drug supply, says a report in Scroll.

Dispensing of drugs is often a question of life and death for patients. A person not trained as a pharmacist is capable of causing death or at least failure of treatment by failing to store drugs properly or by dispensing the wrong drug.

The current penalty for this crime is – under Section 42 of the Pharmacy Act –  imprisonment for a term that may extend to six months or with a maximum fine of Rs 1000 and, under Section 27(d) of the Drugs & Cosmetics Act, a maximum of two years imprisonment and a minimum of one year (with special exception) and a fine of Rs 20,000.

This has been termed as a “minor” punishment for a crime that can also lead to death, say Dinesh Thakur and Prashant Reddy, who have written a book on drugs and regulations, in an article in NewsLaundry.

Referring to the official press release, they say, “The government is being dishonest in portraying the manufacture of this category of defective drugs as a minor offence and hence punishable with a mere fine and not imprisonment. Pharmaceutical companies causing hurt to patients because of their negligence, should be punished with the full force of the law and this should include the possibility of imprisonment.”  

Several experts have also pointed out that despite the employment of pharmacists being mandated under two different legislations with criminal penalties, many pharmacies brazenly violate this requirement by operating without employing any registered pharmacists. How, then, can this be considered a “minor offence”? they question.

Take, for example, the case of State vs Indulal Bogilal Shaha, where the owner of a pharmacy pled guilty before the Court of the Judicial Magistrate First Class, Raigad, to running a pharmacy without a registered pharmacist. The court merely sentenced the owner to “simple imprisonment till the rising of the court”, allowing him to leave once the judge rose from the bench and a fine of Rs 20,000. This was possible by invoking the “special reasons exception” in the provision, as cited by Scroll in its article.

Public health activists also feel that the law is already so lenient, hence decriminalisation of both Section 42 of the Pharmacy Act, 1948, and Section 27(d) of the Drugs & Cosmetics Act, 1940, may lead to further risks for public health. The legislation proposes amending Section 42(2) to delete the imprisonment clause and replace it with a mere fine of Rs 1 lakh. It also proposes making Section 27(d) compoundable on payment of Rs 5 lakh, meaning that if the owner of the pharmacy is ready to cough up Rs 5 lakh, they do not have to go to prison.

"This Bill fulfills a long standing wish list of the industry that if you suffer bodily harm from substandard medicine, no one will be held punitively accountable," public health activist, Dinesh Thakur, said in a series of X posts, earlier called tweets, critiquing the amendments.

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