Why Are Indian Drugmakers Under the Lens?

What’s in today’s article?

• Why in News?
• Background
• Why Are Regulators Failing to Take Action Against Faulty Manufacturing Practices?
• Why Are Pharma Companies not Punished?
• About Drug Controller General of India (DCGI)

Why in News?

• Nigerian health agency has flagged off two drugs — oral paracetamol and another cough medicine — manufactured by companies based in Mumbai and Punjab for being “sub-standard or found to be containing toxins”.

Background

• Since October last year, Indian pharma companies have been under constant international scrutiny for exporting allegedly contaminated drugs, which have led to deaths of children.
• Apart from Nigeria, Cameroon also sounded an alarm over another cough syrup reportedly made in India when several children died.
• Sri Lanka called out two drugs manufactured in India linking them to adverse reactions in several patients.
• Most recently, Gambia has declared that from July 1, it is running strict quality control checks on all pharma products shipped into the country, before they leave Indian shores.
  • Gambia had reported deaths of at least 70 children related to a contaminated cough syrup made in India, in December last year.
• Uzbekistan had reported death of at least 18 children after consuming cough syrup contaminated with high amounts of diethylene glycol (DEG) or ethylene glycol poured in.
• The complaints from across the world on quality of Indian drugs does not seem to stop.
• Soon after the deaths of children in Gambia and Uzbekistan, the Central Drugs Standard Control Organisation (CDSCO) had cancelled the licence of a pharma company named Marion Biotech.

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Why Are Regulators Failing to Take Action Against Faulty Manufacturing Practices?

• Ideally, when a manufacturer is found to be violating laws especially in cases where there is a threat to life or alleged deaths, a criminal prosecution of the persons who are responsible for manufacturing and marketing the drug should be launched.
• Instead of doing that, the Ministry of Health, CDSCO and the state regulator keep passing the buck.
• Also, State Food and Drug Administration bodies are not mandated to disclose the reports of inspections conducted by them on the pharma manufacturing facilities that fall under their jurisdiction.

Why Are Pharma Companies not Punished?

• It is important to note that the licensing and prosecutions of pharma companies is the responsibility of State governments.
• Under the Drugs and Cosmetics Act, 1940, manufacturers not adhering to good manufacturing practices can be subjected to a maximum punishment of imprisonment for life.However, when prosecutions are filed, the cases move at a snail’s pace in courts.
• For instance, in Andhra Pradesh, of the 54 judgments in cases filed against pharma companies between 1999 and 2017, the state was able to secure convictions in only eight cases.
• Poor conviction rate was due to glaring errors committed by drug inspectors including shoddy paperwork, failure to seize, record its condition of storage and label the samples properly, as also the failure to complete the testing process of samples before its expiry date.
• CDSCO is perennially reeling under a shortage of drug inspectors.
  • A 2019 report said that while there ought to be one drug inspector for every 50 manufacturing units and 200 pharmacists, there were vacancies in most States waiting to be filled.
• Karnataka was working at nearly half its sanctioned capacity for drug inspectors, while Himachal Pradesh had 27% vacant posts.

About Drug Controller General of India (DCGI)

• Drugs Controller General of India is the head of department of the Central Drugs Standard Control Organization (CDSCO).
• The CDSCO is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act, 1940.

Image Caption: Functions of CDSCO

• Nodal Ministry – Ministry of Health & Family Welfare

Q1) What is the definition of drug resistance?

Drug resistance is simply defined as the ability of disease-causing germs (e.g., bacteria or viruses) to continue multiplying despite the presence of drugs that usually kill them.

Q2) How big is the pharmaceutical industry in India?

India’s domestic pharmaceutical market is estimated to reach USD 130 billion by 2030 and the pharma industry has sustained its growth momentum after the pandemic, according to the Economic Survey 2022-23.

Source: Explained | Why are Indian drugmakers under the lens? | Business Standard