A new legislation that mirrors the old – On Drugs regulations in India

Source: This post is created based on the article “A new legislation that mirrors the old” published in The Hindu on 20^th July 2022.

Syllabus: GS Paper 2 – Social Issues – Issues related to health

News: The Union Health Ministry recently published a new draft Bill to replace the antiquated Drugs and Cosmetics Act, 1940. However, the bill seems to lack the provisions that can address the burning issues in the sector.

The Drugs and Cosmetics Act, 1940 was introduced, when the drug industry was in its infancy, now it is antiquated. It was based on the following procedure:

1) Drug inspectors purchasing manufactured drugs from an open market > 2) if a drug fails quality testing, the manufacturer will be punished.

What is the need for changing the regulations in drug industry?

Absence of provision of Good Manufacturing Practices (GMPs)

1) The present system is based on luck, if on a certain day, a good quality product fails a test, the manufacturer will be punished or vice versa.

2)  Much of the world has shifted to a more rigorous system of regulation centred on the compliance of manufacturing units with good manufacturing practices (GMPs). A drug manufactured in compliance with GMPs is unlikely to fail tests in the market due to the quality checks it goes through.

3) In the U.S., the law presumes that any drug that is manufactured in a facility and fails to comply with GMPs is ‘adulterated’. U.S. law mandates drug inspectors to publish reports of inspection.

Whereas, in 1988, India incorporated a system of GMPs via government rules, instead of Parliament, with no criminal penalties for companies failing to comply with GMPs. Even, drug inspectors are not liable to publish their reports. Many evidences prove that such inspections are not carried out.

Regulatory Structure

India has 37 agencies for enforcing drug regulation, including one in each State and Union Territory, Central Drugs Standard Control Organisation (CDSCO) at the center.

• State drug controllers license drug manufacturing and conduct enforcement actions such as sampling, testing, and prosecution for substandard drugs.
• CDSCO regulates imports and decides if new drugs have adequate clinical evidence before they can be sold.
• Health ministry lays down rules and regulations and bans drugs with no supporting clinical evidence.

Now, the issue arises, when the states like Himachal Pradesh (HP), do not enforce the Drugs and Cosmetics Act properly. HP accounts for the bulk of pharmaceutical manufacturing on account of a tax holiday. They fear, it will stop the investments by the pharmaceutical industry.

The problem increases, as the drugs from states like Himachal Pradesh are sold across the country, even in the states with more competent drug regulators.

Regulatory bodies

Drug regulations give discretionary power to the unelected bureaucrats for approving a new drug or a new manufacturing facility. However, the process is not transparent.

What are the issues with the new draft bill?

Even the new bill does not provide for the provisions of GMP.

The bill does not address the need for a single regulator.

The new law doesn’t address the critical issue of transparency.

The proposed legislation does not make accommodations for public participation.

What should be done?

Mashelkar Committee in 2003 had recommended centralizing drug licensing with the central regulator.

The law should guarantee proactive disclosure of all crucial documentation related to regulatory decisions on the approval or rejection of drugs.  If a new drug is being approved, the regulator should be required to disclose all the data, including clinical trial data.

Each inspection for GMP compliance should conclude with an inspection report accessible to the general public.

Public participation in the regulatory process should be made legal by allowing public hearings or citizen petitions to question regulators and explain their rationale for approving the new drug.