Slap on the wrist
Amidst the din in the Lok Sabha last week, the government quietly passed, without debate, a bill that in effect takes the sting out of some of the punitive measures applicable to drug manufacturers who put substandard medicines into the market, a phenomenon that is rampant. Typically for this government, this measure has been camouflaged under several layers of obfuscation and cosmetic intent.
The Jan Vishwas (Amendment of Provisions) Bill, 2023 purports to decriminalise ‘minor offences’ covered by 42 central acts pertaining to drugs, the environment, agriculture, media, industry and trade, among others. Winkling out ‘archaic laws’ from the statute is a thing with this government. It plays skeet with them every year, consigning dozens of provisions to the dustbin of history, always without debate, always under the ruse of reducing the burden of compliance and promoting the ease of doing business. This latter is a phantom child of this government: one hears a lot of it but there’s nothing to see.
The bill passed last week amends 183 provisions spread over 42 acts. Among such laws tinkered with is the Drugs and Cosmetics Act 1940, specifically, a provision within it that mandates criminal prosecution, and imprisonment up to two years if found guilty, for a manufacturer whose drugs are found to be substandard. If the Jan Vishwas Bill gets presidential approval, such offences will attract compounding, that is, a fine of Rs 5 lakh but no prosecution.
The government argues that this is meant to remove the threat of litigation that handicaps the growth of the pharma industry. Further, it applies only to drugs found to be NSQ, not of standard quality; other categories of bad drugs, such as spurious drugs or adulterated ones, will continue to attract prosecution and jail terms.
This is a classic legislative dodge. Removing the effective deterrent of prosecution amounts to giving a get-out-of-jail-with-penalty card to the drug industry. While spurious drugs or medicines adulterated with toxic substances can be directly life-threatening, NSQ drugs are no less a menace, nor any less rampant. Drugs with below-norm concentration of active ingredients are the more common form of pharma fraud seen in India, and they can lead to dire situations too by allowing medical conditions to worsen or leading to development of resistant pathogens. In fact, just three days before the Jan Vishwas Bill was passed in the Lok Sabha, the government revealed that between April 2021 and March 2022, more than 2,500 drug samples were found to be NSQ and 379 as spurious. How does going lenient against a flagrant phenomenon lead to better health outcomes?
How will this leniency aid India’s ease-of-doingbusiness ranking if it at the same earns the pharma industry a reputation of low standards? Already, since the scandal of contaminated cough syrup exports to Gambia, India’s pharma flag is not exactly flying high, with regulators in several countries subjecting Indian imports to laser-sharp scanning. Even the industry lobby ASSOCHAM has estimated that fake or substandard drugs constitute 25 percent of the Indian drug market.
What Indian pharma needs is not lenient laws that overlook minor divergences from the norm but tighter regulation, more frequent inspections and a nationwide regulatory framework. We need to live up to the self-awarded honour of being the pharmacy of the world.
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