Does the “Jan Vishwas Bill”, recently passed by both houses of Parliament, pave the way for ease of doing business, at the expense of public health?
Legal experts and public health voices say that is not the case, as serious deviations are punishable under the law. And on the contentious issue of non-standard drugs (NSQ), they said, it would also be assessed on severity, in that a chipped tablet may be viewed differently from a medicine that did not have the required active ingredient of the drug, for example.
On Wednesday, the Rajya Sabha too passed the Jan Vishwas (Amendment of Provisions) Bill.
Responding to whether the Bill watered down penalties for drug companies selling NSQs, Krishna Sarma, Managing Partner with Corporate Law Group told businessline, “Not really. The Bill has added Sec 27(d) to the provisions listed in Sec. 32B for compounding of certain offences under the Drugs and Cosmetics Act, 1940. Sec. 27 (d) provides penalties for manufacture and sale of misbranded and NSQ drugs. The catch is that under Sec. 32B, offences punishable with imprisonment or with imprisonment and fine are not compoundable, while the punishment under Sec. 27 (d) is imprisonment of up to two years and fine. ….. unless Sec. 27 (d) is amended, listing it for compounding is meaningless.”
Besides, she added, the Health Ministry has clarified that compounding has been offered “as a mechanism for resolution of a litigation…the quantum of punishment prescribed in Sec. 27(d) has not been reduced if found guilty.”
Further, she pointed out, “Laws for manufacture and sale in India are indeed strict. …. punishment (of) adulterated or spurious drugs leading to death or grievous injury is punishable up to life imprisonment (Sec. 27(a)); other adulterated drugs operating without a license is punishable with imprisonment of up to five years (Sec. 27 (b)); and other spurious drugs are punishable with imprisonment up to seven years (Sec. 27(c)). ”
S Srinivasan with the All India Drug Action Network (AIDAN), and Locost (a maker of inexpensive medicines) explains that penalties for serious deviations in a product, have not been changed. “The amendment involves compounding in the case of certain first time offences of NSQ drugs covered by Sec 27 (d). Subsequent offences are not compoundable. It comes down to implementation, and incorruptibility of the system, among other things, he said.
Several seasoned public health voices explain, the modification being made is for authorities to offer a plea, for a “first time”, non-severe offence. This is not an entitlement for manufacturers, they said, adding that repeat offences would be punished.
The pharma industry is directly impacted by the change, and Sudarshan Jain with the Indian Pharmaceutical Alliance (IPA) says, the law prioritises quality, as punitive action is outlined for spurious drugs. IPA represents large domestic drugmakers.
The Bill was introduced with the aim of decriminalising and rationalising minor offences to further enhance trust-based governance for ease of doing business, says Sidharrth Shankar, Partner, JSA. Though the Centre did clarify that penal provisions remain for NSQ drugs, the offence has been made compoundable, implying that imprisonment of two years, may no longer be a penalty.
This could send out “a mixed signal that manufacture of NSQ drugs could be a minor offence which could be compounded by paying the maximum penalty. This does seem to give out a suggestion that the manufacturer may not be liable for imprisonment for manufacture of an NSQ drug.
In light of India’s recent bad publicity in the global pharma market vis-à-vis cough syrups manufactured in and exported from India, this may not be a very welcome move,” he pointed out.
The Bill also proposes decriminalisation of Section 42 of the Pharmacy Act, 1948, says Somdutta Singh, Founder and Chief Executive, Assiduus Global Inc. With the proposed amendment to Section 42(2) of the Pharmacy Act, the penalty for violations may now be reduced to a mere fine of ₹1 lakh. There are concerns on the potential consequences of such leniency, particularly if pharmacies operate without qualified pharmacists etc, she pointed out.