Bill to ease penalties for low-quality drugs passed in Parliament

The Rajya Sabha on Wednesday passed the Jan Vishwas (Amendment of Provisions) Bill, 2023, that seeks to promote ease of business by decriminalising minor offences, amending 183 provisions in 42 acts across 19 Union ministries, in some cases replacing prosecution with direct penalties.

The changes proposed to the Drugs & Cosmetics Act, 1940, through this Bill include permission for compounding— paying a fine in lieu of imprisonment—for substandard medicines, a modification that has sparked a huge debate among experts who fear it will lead to dilution of punishment, with activists claiming that this has been done at the instance of the pharma lobby.

The Drugs and Cosmetics Act, 1940, classifies drugs as “adulterated, spurious, and not of standard quality (NSQ).

Punishments in section 27 of the Drugs and Cosmetics Act, 1940 under section 27 (d) are jail terms up to two years for NSQ drugs.

Under the new legislation, section 27 (d) has been made compoundable; in effect, going easy on manufacturers producing substandard drugs.

“Desh Vishwas pe chalega (the country will function on faith),” said Piyush Goyal, minister of commerce and industry, while arguing in favour of the Bill in Rajya Sabha.

“Agar koi gambhir galti karta hai toh jail avashya milni chahiye; saral jo galtiyan hoti hain, ya pehli baar jo galtiyan hoti hai toh unke liye saral vyavyastha ho (If a serious offence has been committed, there should absolutely be jail term for the offenders but for simple crimes we should try to have simple measures,” the commerce minister added

The stand of the government on the issue has been a point of contention among pharma experts who fear it will help manufacturers who will get away by paying a fine.

Dinesh S Thakur, pharma expert and co-author of The Truth Pill: The Myth of Drug Regulation in India, said, “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… appears to trivialize the issue of sub-standard drugs; but the biggest threat to public health in India from the pharma industry is sub-standard drugs not counterfeit drugs.”

When asked about the dilution proposed in the law, Union health minister, Mansukh Mandaviya,who held a press briefing on Wednesday, reiterated Goyal’s stand. “While the government has to ensure quality of drugs is maintained as we are the pharmacy of the world, there is also the need to create a conducive ecosystem for manufacturers. We have to encourage manufacturers; therefore, there should not be harsh punishment for minor crimes.”

“The punishment has not been reduced; only made compoundable,” he added.

The Lok Sabha passed the bill on July 27 in the current session, and in response to the outrage that followed, the health ministry issued a detailed statement on why it wasn’t a harmful step.

“This section which has been made compoundable with regards to manufacture, sale etc. of drugs which are not adulterated, spurious, or manufactured without a license or manufactured in contravention of any prohibition but have been found to be in violation of the Drugs & Cosmetics Act, the quantum of punishment prescribed in 27 (d) has not been reduced. If found guilty, the imprisonment is still not less than one year which may extend to two years,” read the health ministry statement.

“It has not been decriminalized but compounding has been offered as a mechanism for resolution of the litigation,” it added.

A pharma regulations expert, requesting anonymity, said, “Taking substandard medicines may not kill but imagine finishing a course of antibiotic and still not getting better because the drug was substandard. It will obviously harm the patient.”