Jan Vishwas Bill: Will manufacturers of substandard drugs get away with just a fine?
Context- The Jan Vishwas Bill passed in the Rajya Sabha yesterday (August 2) will amend two provisions of the law governing manufacture, storage, and sale of medicines in India.
One of the amendments has led to a debate on whether manufacturers of substandard medicines would be let off easy – by paying a fine instead of imprisonment.
(Credits- The New Indian Express)
The Jan Vishwas bill was brought to the parliament with an aim to improve ease of doing business. It will amend 183 provisions across 42 laws to do away with imprisonment or fines for certain offences.
What changes does the Jan Vishwas bill make to the drug law?
- The Jan Vishwas Bill will make two changes to the Drugs and Cosmetics Act, 1940.
- The first amendment, which is not contentious, will do away with imprisonment under section 30 (2) of the current law for companies repeatedly using government analysis or test reports for promoting their products.
- At present, companies face up to two years imprisonment and a fine of not less than ten thousand rupees for a repeated violation. This will change to only a fine but not less than five lakh rupees as per the amendment proposed in the Jan Vishwas bill.
- The second amendment – and this is the contentious one – will change section 32B (1) of the existing law to allow “compounding” of offences under section 27 (d). Compounding is a legal provision that allows one to pay a fine instead of undergoing criminal proceedings.
- Section 27 of the existing Drugs and Cosmetics Act has provisions for punishments for different types of offences — a) adulterated or spurious drugs that lead to death or grievous injury carrying a sentence of up to life imprisonment, b) adulterated medicines that do not fall under the previous category of medicine manufactured without a licence carrying a sentence of up to five years, and c) spurious medicines other than the ones that fall under the first category carrying a sentence of up to seven years. Section 27(d) covers any offence not covered under a, b, and c category.
- While the existing drug law already allows for compounding other offences, the reason many have raised an issue with including section 27 (d) is because it also includes drugs that are not of standard quality (NSQ), colloquially referred to as substandard drugs.
What kind of offenses by drug manufacturers could be compounded?
- The provisions will be available to manufacturers whose drugs might be NSQ. A drug being NSQ means that it fails some of the requirements set for that particular product by the Indian Pharmacopoeia.
- This would include drugs that fail dissolution test (measure the rate at which a tablet or capsule releases the active ingredient in the body) or those that do not contain the full dosage of medicine as mentioned on the medicine cover.
- The government, however, maintains that the provision for compounding will be available to manufacturers who face imprisonment for charges with minor aberrations or quality control measures.
- In several cases under section 27(d) the drug inspectors painstakingly prepare a case, it stays in court for years, and then the manufacturer anyway has to just pay the fine. Or, sometimes companies with minor deficiencies they are willing to correct are stuck in litigation for years. Compounding is an alternate mechanism in these cases.
- This will not be available to companies that are repeat offenders. The government does have a list of offenders and compounding will be decided based on that.
What has it got to do with good manufacturing practices?
- The drug act in the schedule M lists all the requirements such as space or processes for drug manufacturers. The changes that were made to this schedule in 2018 to improve drug manufacturing in the country are yet to be adopted by a majority of drug manufacturers.
- The health ministry on Wednesday said that bigger companies with a turnover of over 250 crores will need to implement these measures within six months and smaller companies within a year.
What do manufacturers say?
Manufacturers say allowing compounding is actually a good move and prevents companies from being stuck in litigation for years for minor offences.
Way Forward- Allowing compounding of some offences but strict punishment for repeat offences or offence with the intent will not only help the pharmaceutical industry flourish but also ensure that they make quality products
Syllabus- GS-2; Legislature
Source- Indian Express