Jan Vishwas Bill, 2023

  • Recently, the Jan Vishwas (Amendment of Provisions) Bill, 2023 was passed in Lok Sabha during the monsoon session and aims at giving a boost to Ease of Living and Ease of Doing Business.

Jan Vishwas Bill

  • Introduced by Commerce and Industry Minister.
  • Aim: Giving further boost to ease of living and ease of doing business.
  • The Jan Vishwas, also known as the Amendment of Provisions Bill, 2022: It makes modifications to 42 laws that cover a wide range of topics, such as agriculture, the environment, media and publication, and health.
  • Converts a number of different fines into penalties, which means that legal action is no longer required in order to carry out punishments.
  • Removes imprisonment as a punishment for many offences.
  • Changes in the Drugs and Cosmetics Act, 1940, the Food Safety and Standards Act, 2006 and the Pharmacy Act, 1948 are also covered under the bill.
  • Among these, the changes proposed to the Drugs and Cosmetics Act, 1940 have been the most contentious.
    • The Act regulates the import, manufacture, distribution and sale of drugs and cosmetics in the country.
  • Currently, the Act defines four categories of offences:
    • adulterated drugs
    • spurious drugs
    • mislabelled drugs
    • Not of Standard Quality drugs (NSQs)
  • It lays out degrees of punishment (a combination of prison time and fine) based on the degree of offence.

Key Laws Covered in the Bill

  • The Indian Forest Act, 1927.
  • The Air (Prevention and Control of Pollution) Act, 1981.
  • The Information Technology Act, 2000.
  • The Environment (Protection) Act, 1986.
  • The Copyright Act, 1957.
  • The Patents Act, 1970.
  • The Railways Act, 1989.
  • The Food Safety and Standards Act, 2006.

The first amendment:

  • It 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.

The second amendment:

  • It will change section 32B (1) of the existing law to allow “compounding” of offences under section 27 (d).
  • What this essentially means is that companies violating the provisions of 27 (d) will continue to face imprisonment between one and two years and a fine not less than R20,000.
  • Now there will be an alternative mechanism where the company could agree to pay the fine instead of going through a criminal proceeding in court.

Criticism of the bill

  • First, it allows manufacturers of Not of Standard Quality Drugs (NSQ) drugs to escape significant penalties despite the fact that these drugs can have an adverse effect on the patient.
    • For example, drugs that lack the adequate active ingredient or fail to dissolve will not cure the disease it is meant to and that will result in a poor treatment outcome for the patient.
  • Second, the Bill also reduces penalties for owners of pharmacies who violate the terms of their licence.
  • The Indian pharmaceutical sector, manufacturing and pharmacies included, are already subject to extremely lax regulation as evidenced by the explosion of scandals recently across the world linked to ‘Made in India’ medicine.
  • The government should be tightening the regulatory screws, not giving the industry a literal “get out of jail” pass.

Government’s stand

  • The provision for compounding will be available to manufacturers who face imprisonment for charges with minor aberrations or quality control measures.
  • Compounding will prevent long litigation and reduce the burden of courts.
  • Eg, 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.
  • The compounding will not be available to companies that are repeat offenders.

Good manufacturing practices and section 27 (d)

  • The Schedule M of the Drug Act 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 bigger companies with a turnover of over 250 crores will need to implement these measures within six months and smaller companies within a year.
  • Those who do not implement the measures within the stipulated time will also be prosecuted under section 27 (d).

About Not of Standard Quality (NSQ) drugs

  • A drug being an NSQ drug means that it fails some of the requirements set for that particular product by the Indian Pharmacopoeia.
  • This would include drugs that fail the 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.

About Section 27 of the Drugs and Cosmetics Act

  • Section 27 of the existing Drugs and Cosmetics Act has provisions for punishments for different types of offences
    • adulterated or spurious drugs that lead to death or grievous injury carrying a sentence of up to life imprisonment,
    • 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
    • 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 the a, b, and c categories.

Way forward

  • The laws shouldn’t become a cost-to-operation component for companies but should install in them the greater sensibilities and responsibilities towards the society.
  • India is the pharmacy of the world and we have to work towards ensuring that the best medicines are provided while reasonable benefits are offered to business.
  • Rationalising laws, eliminating barriers and bolstering growth of businesses are important.