Changes to Drugs and Cosmetics Act seem justified
August 02, 2023,
The Jan Vishwas (Amendment of Provisions) Bill, 2022, recently passed in the Lok Sabha, decriminalises about 180 minor offences across 42 central laws spanning pharma, media, agriculture, the environment and industry. By converting or “compounding” prison sentences into fines and penalties, the new law will enable businesses to breathe freely. However, the recent debate around the Bill has centred around its amendments to the Drugs and Cosmetics Act, 1940.
The debate on social media has been a misinformed one. Spurious and adulterated drugs will continue to be liable for criminal punishment, without any change in terms. The compounding of offences applies in two cases: repeated advertisements of a product citing government data; and to deviations (less serious ones) with respect to drugs that are ‘not of standard quality’ (NSQ). The NSQ guidelines were laid down by the Central Drugs Standard Control Organisation in 2008. NSQ lapses can be compounded if the investigating authorities agree. Indeed, the fear of imprisonment for minor slips could deter bonafide industry entrants. The Bill takes a realistic view of minor deviations from NSQ norms by reviewing Section 27d of the Drugs and Cosmetics Act. The section implicitly and broadly refers to NSQ lapses (and this excludes drugs that are spurious, adulterated or made without a licence) which can lead to a prison term of up to two years. Contrary to what the critics have said, the imprisonment option still exists under Section 27d, since ‘NSQ’ refers to a range of lapses. But compounding is an active option now, and rightly so.
This contentious section has been tagged to one that deals with compoundable offences. A distinction in punishment should be made between putting out fake and adulterated drugs on the one hand and, say, broken or chipped tablets, or those with labelling errors. The 2008 guidelines suggest an investigation process as well. It is clear that the decision on whether a particular lapse under Section 27d is to be ‘compounded’ is left to the investigators. However, some clear guidelines for them will help rule out malpractices and truly ease compliance for stakeholders.
According to the National Drug Survey 2014-16, conducted by the Health Ministry, 3 per cent of the medicines were found to be NSQ at the retail level and 10 per cent at the government level; this is a finding from the collection of over 47,000 samples all over the country. Spurious samples were truly negligible. Encouraging as this seems, there were outliers with high NSQs such as erythromycin (29 per cent), gentamicin (21 per cent), amikacin (19.5 per cent), ORS (12 per cent) and pantaprazole (11 per cent). Eye drops too are suspect. These NSQ figures should be taken seriously, even if the overall figure is low. In sum, a liberalised business environment and quality control in pharma should go hand in hand. The Jan Vishwas Bill makes this possible.
THE HINDU businessline