Recently, the Union Ministry for Health & Family Welfare published a new Bill to replace the colonial-era Drugs & Cosmetics Act, 1940.
What is the key contentious provision?
- While most of the new Bill is a copy of the old legislation, some of the proposed revisions treat drug quality as a divisible concept, wherein it is presumed that a drug will work even if it fails on certain quality parameters.
- Either a drug passes all quality standards laid down by a government body called the Indian Pharmacopoeia Commission (IPC), which publishes the standards in a publication called the Indian Pharmacopoeia (IP), or else the drug fails in treating patients.
- Historically, since 1940, drugs failing quality testing in accordance with standards published in the IP have been declared Not of Standard Quality (NSQ), making the manufacturer liable for minimum imprisonment of one year and maximum imprisonment of two years and a fine of Rs 20,000 with special exceptions.
- The rationale for criminal punishment in cases of drug quality is simple: Unlike other products, quality issues in the manufacture of drugs have direct implications on the health of citizens.
What is being proposed in the bill?
- The new approach proposed by the government to regulation is aimed at accommodating the pharmaceutical industry’s demand to “decriminalise” some of the offences under the existing law.
- Section 56(e) of the new Bill proposes lowering punishments for drugs that have been declared NSQ due to any of the 43 defects listed in the fourth schedule of the Bill. For such defects, manufacturers are liable for lower imprisonment of one year and a fine of Rs two lakh, while for defects that do not fall within the fourth schedule, the manufacturer is liable for a higher punishment of up to two years imprisonment and a fine of Rs five lakh.
- The lower punishments for fourth schedule defects, however, hide the true intent of the law, which can be found in section 71. This provision, which is basically the icing on the cake for the pharmaceutical industry, allows for the compounding of a class of offences including those defects in the fourth schedule. “Compounding” means the prosecuting drug controller has the discretion to waive a trial and prison time as long as the accused pharmaceutical company agrees to pay the fine. In effect, the industry has achieved its goal of “decriminalisation”.
- The cherry on top of the icing is section 58 of the Bill, which gives the government the power to expand the list of exceptions in the fourth schedule. Given the political might of the pharmaceutical industry, it will most definitely succeed in forcing the government to expand beyond the current 43 exceptions.
What does it mean?
There is no moral or scientific case to justify treating some manufacturing defects more seriously than others when the standard setting body — the IPC — is very clear on the scientific requirements for a drug to be declared of standard quality.
The larger takeaway from this episode is that much of India’s drug regulatory apparatus continues to serve the interests of the pharmaceutical industry, and not public health. In 2012, the Parliamentary Standing Committee on Health had levelled this same charge against the Central Drugs Standard Control Organisation, which is headed by the DCGI. That this romance between the regulator and the industry has crept into the law-making process is cause to junk this version of a Bill.
Source – The Indian Express
QUESTION – The new Drugs Bill that is set to replace the colonial-era Drugs and Cosmetic Act of 1940 is being criticised for serving the interests of pharmaceutical industry, and not public health. Critically discuss the provisions of the proposed bill and analyse the same.