The Lok Sabha on July 29 passed the 108-page Jan Vishwas (Amendment of Provisions) Bill during the monsoon session of Parliament. The bill was first introduced in December last year and later referred to the joint committee of parliament for review.
It essentially proposes to decriminalise 183 provisions in 42 legislations, in order to promote ease of doing business in the country. This means it aims to redefine the regulatory landscape and decriminalise small offences, get rid of outdated rules and regulations and rationalise monetary penalties.
Law Minister Arjun Ram Meghwal said the NDA government has repealed 1,486 laws and once the present bill gets Parliament’s nod, the number of laws removed from statute books will go up to 1,562. Presently, the bill covers the Boilers Act, the Aadhaar Act, 2016, the Legal Metrology Act, 2009, the Collection of Statistics Act, the Government Securities Act, 2006, and The Food Safety and Standards Act, 2006, among others. The bill is part of periodical measures taken up to repeal enactments that have ceased to be in force or have become obsolete.
So, among the changes made to several acts, there are certain changes applied to two sections of the Drugs and Cosmetics Act, 1940, which governs the manufacturing, storage and sale of medicines in India. This has sparked a debate that it will allow drug makers to get off lightly on charges of making substandard medicines. One of the amendments proposed under the Bill will allow compounding — paying a fine instead of facing imprisonment — for some offences.
The first amendment seeks to change the punishment for a repeated offence of using a government analysis or test report for advertising a drug. The previous punishment was imprisonment up to two years or a fine of more than Rs 10,000, which has now been proposed to only a fine, but more than Rs 5 lakh. The second amendment allows for “compounding”, that is, paying a fine instead of undergoing criminal proceedings for drugs not of standard quality (NSQ), as defined under Section 27 (d) of the 1940 Act.
The health ministry said compounding will be allowed only for drugs that have not failed parameters considered injurious to health, that do not contain toxic substances, that do not contain substance which reduce quality or strength of a drug, that haven’t been manufactured in unsanitary conditions, that haven’t been manufactured without a licence, and that do not have any misleading labels.
However, activists argue that drugs not of standard quality as listed in Section 27 (d) could be unsafe and harmful. Tweeting on the issue, Dinesh Thakur, who works in the area of drug regulation, said the press release issued by the ministry claims that Section 27(d) which prescribes criminal punishment of manufacturers of NSQ drugs has not been “decriminalised”. “Technically, that’s correct since it makes the offence compoundable, that is, pay the paltry fine and escape jail time,” he said.
The point of debate is: Why have the penalties been drastically reduced and why will companies not have to face imprisonment for substandard drugs, also called the NSQ drugs? There have been cases where pharma companies in the country have produced substandard drugs in the past and if this happens again, these drug makers will not face imprisonment and instead they can get away by just paying paltry fines. Industry owners have long wanted that minor offences to be decriminalised so as to totally waive off the terms for imprisonment. That will now be answered through the fresh amendments.
The question is if drugs that do not conform to the standards in the Indian Pharmacopeia and are considered to be NSQ reach the market, will the offenders be imprisoned?