Indian Pharmaceutical Industry and Drug Safety

In Context

• Reports of drugs manufactured in India causing severe harm and dozens of patient deaths from across the world continue to trickle in.

Controversial reports on drugs manufactured in India

• Anaesthetic drugs:
  • Latest of the reports is the deaths of two patients in Sri Lanka who were administered Indian-made anaesthetic drugs. 
• Eye drops:
  • Just last month, eye drops manufactured in India had caused eye infection in about 30 patients and blindness in 10 in Sri Lanka. 
  • While anaesthetic drugs made in India causing deaths are a first in the recent past, eye drops causing infections, blindness and even deaths were reported a few months ago in the United States, with the Atlanta-based Centers for Disease Control and Prevention (CDC) finding a highly drug-resistant bacteria in them.
• Cough syrups:
  • The series of adverse reports against drugs produced in India began last year when the World Health Organization (WHO) linked the deaths of at least 70 children in Gambia from acute kidney injury to cough syrups. 
    • The culprit ingredient in the syrups was diethylene glycol and ethylene glycol — deadly chemicals used as a cheaper substitute for propylene glycol — that should never have been found in any medicine. 
  • Soon after the deaths in Gambia, cough syrups made in India and containing the two deadly chemicals killed 18 children in Uzbekistan in December 2022. 
  • Indian-made cough syrup was again in the news when WHO flagged the contaminated drugs found in the Marshall Islands and Micronesia; the contamination was identified by the Australian regulator.

Indian Pharmaceutical industry

• The Pharmacy of the World:
  • The Indian Pharmaceutical industry is the third largest in the world by volume. 
    • The Indian Pharmaceutical Industry has been using its powers very responsibly. 
    • It has made a name for itself and India is being called “The Pharmacy of the World” in some circles.
• Export:
  • India exported pharmaceuticals worth Rs 175,040 crore in the financial year 2021-22, including Bulk Drugs/Drug Intermediates. Also, India is one of the major producers of Active Pharma Ingredients (API) or bulk drugs in the world. 
  • India exported Bulk Drugs/Drug Intermediates worth Rs 33,320 crore in the financial year 2021-22.
• Imports:
  • However, the country also imports various Bulk Drugs/ APIs for producing medicines from various countries. 
    • Most of the imports of the Bulk Drug/APIs being done in the country are because of economic considerations.
• What is driving the growth?
  • Talent pool:
    • India has a huge talent pool with trained pharmaceutical professionals having degrees in B Pharmacy, D Pharmacy, M Pharmacy. 
  • Generic drugs:
    • The ability of the pharmaceutical industry to develop generic drugs at a much-reduced price is mainly due to trained professionals in the industry. 
  • Manufacturing:
    • India has a huge manufacturing base of pharmaceutical products giving it way more flexibility in producing generic drugs. 
    • India is home to 3000 drug companies and more than 10,000 manufacturing units.

• Potential of the Indian Pharmaceutical Industry:
  • According to the Indian Economic Survey 2021, the pharmaceutical industry in India is expected to reach USD 120-130 Billion by 2030. 
  • Industries related to the pharmaceutical sector:
    • The other industries related to the pharmaceutical sector like biopharmaceuticals, bio-services, bio-agriculture, bio-industry, and bioinformatics are likely to reach USD 150 Billion in 2025 as compared to USD 70 Billion in 2020.
  • According to EY and FICCI, Innovation and R&D, Healthcare Delivery, Manufacturing & Supply Chain, and Market Access are the opportunities that will drive growth in the years to come. 

Challenges

• Safety of drugs:
  • Except for some customary inspections, the Indian drug regulator has so far failed to institute measures to make sure drugs produced in India for export and domestic use are safe. 
• Failing the quality tests:
  • According to a Central Drugs Standard Control Organization (CDSCO) survey in 2014-2016, about five per cent of Indian drugs, several of them manufactured by large pharma companies, failed the quality test. 
  • Independent studies suggest that this figure could be much higher. 
  • The country’s pharma industry has largely been in denial over quality-related concerns expressed by national and international observers. 
• Costs of production:
  • The cost of production in India is 50 percent less than in developed nations, but it is still around 18 percent higher than China. 
  • This is attributable to raw materials being 25-30 percent costlier, electricity being 20 percent more expensive, and other costs such as financing, logistics, transportation, etc., being 30 percent more expensive.

Regulation of Drugs in India

• Drugs and Cosmetics Act, 1940: 
  • The Act regulates the import, manufacture, and distribution of drugs in India.
  • The primary objective of the act is to ensure that the drugs and cosmetics sold in India are safe, effective and conform to state quality standards.
  • The Drugs and Cosmetics Act, 1940 was amended by the Drugs & Cosmetics (Amendment) Act, 2008 to provide for more stringent penalties for manufacture and trade of spurious and adulterated drugs.
• New Drugs, Medical Devices and Cosmetics Bill, 2022: 
  • To accommodate changing requirements and encourage the adoption of new technology, the Ministry of Health and Family Welfare released a draft bill in July 2022 to replace the existing Drugs and Cosmetics Act 1940. 
  • This act governs drug importation, production, and distribution across the country.
• Central Drugs Standard Control Organization: 
  • It is the apex department of the Central Drugs Standard Control Organization (CDSCO) of the Government of India.
  • CDSCO is a regulatory body for Indian pharmaceuticals and medical devices.
  • It comes under the Ministry of Health and Family Welfare.
• Drugs Controller General of India: 
  • Drugs Controller General of India (DCGI) is the head of department of the Central Drugs Standard Control Organization of the Government of India 
  • It is responsible for approval of licences of specified categories of drugs such as blood and blood products, IV fluids, vaccines, and sera in India. 
  • DCGI also sets standards for manufacturing, sales, import, and distribution of drugs in India.

Way ahead

• India needs to make sure that inspection records and reviews of drug applications are made public, and put all generics manufacturers through the same tests as companies making new drugs.
• Doubts about Indian drugs will have dangerous ripple effects. 
• India can continue to be the pharmacy of the global south only if the regulator begins to behave like a watchdog to ensure drug safety, and not as a facilitator for the pharma industry.