India’s Pharmaceutical Industry

• 20 May 2023

For Prelims: India's pharmaceutical industry, World Health Organization (WHO), Central Drugs Standard Control Organisation (CDSCO), Intellectual Property Rights (IPR) laws, Production Linked Incentive (PLI) Scheme.

For Mains: Status of India's Pharmaceutical Industry, Major Challenges with India’s Pharma Sector.

Why in News?

India's pharmaceutical industry, renowned as the largest manufacturer of generic medicines globally, has faced significant challenges related to product quality and safety.

• Recent incidents of contaminated medicines and substandard drugs have raised concerns about the regulatory framework and the industry's commitment to ensuring high-quality pharmaceutical products.

What are the Incidents Highlighting Quality Control Failures?

• In January 2020, 12 children in Jammu died after consuming contaminated medicine, that was found to contain diethylene glycol, which led to kidney poisoning.
  • In March 2021, Nycup syrup was found to have lower levels of active ingredients.
• In October 2022, the World Health Organization (WHO) released a medical product alert, which are said to be linked to acute kidney injury in children and 66 deaths in the small West African nation of Gambia.
  • Four products from India-based Maiden Pharmaceuticals had been found to be contaminated with unacceptable amounts of diethylene glycol and ethylene glycol, both toxic to humans.
• In December 2022, the Central Drugs Standard Control Organisation (CDSCO) initiated a probe in connection with the death of 18 children in Uzbekistan allegedly linked to a cough syrup manufactured by Indian firm Marion Biotech.
  • Recently, US Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (USFDA) raised concerns over a drug-resistant bacteria strain allegedly linked to eye drops imported from India.
• Recent regulatory inspections revealed that 48 drugs failed to meet quality standards.
  • 3% of drugs used for common conditions like hypertension, allergies, and bacterial infections were found to be substandard.

What is the Status of India's Pharmaceutical Industry?

• About:
  • India is the largest manufacturer of generic medicines globally. Its pharmaceutical industry plays a crucial role in global healthcare, providing affordable generic medicines that impact the lives of the global poor.
  • It is currently valued at USD 50 Bn being a major exporter of Pharmaceuticals, with over 200+ countries served by Indian pharma exports.
    • It is expected to reach USD 65 Bn by 2024 and to USD 130 Bn by 2030.
• Major Challenges with India’s Pharma Sector:
  • Violation of IPR Rules:
    • Indian pharmaceutical companies have faced allegations of violating Intellectual Property Rights (IPR) laws, resulting in legal disputes with multinational pharmaceutical companies.
    • One such case involved Swiss pharmaceutical company Roche and Indian drug manufacturer Cipla in 2014.
      • Roche accused Cipla of infringing on its patent for the cancer drug Tarceva by producing a generic version of the drug. The dispute escalated, leading to a court battle between the two companies.
      • In 2016, the Delhi HC ruled in favor of Roche, affirming that Cipla had indeed violated Roche's patent rights. As a consequence, Cipla was ordered to pay damages to Roche.
  • Pricing and Affordability: India is known for its generic drug manufacturing capabilities, which have contributed to affordable healthcare globally.
    • However, the pricing of pharmaceuticals within India remains a significant concern. Balancing the need for affordable medicines with the profitability of pharmaceutical companies is a delicate task.
  • Healthcare Infrastructure and Access: Despite India's strong pharmaceutical industry, access to healthcare remains a challenge for a significant portion of the population.
    • Issues such as inadequate healthcare infrastructure, uneven distribution of healthcare facilities, and low health insurance coverage pose barriers to accessing medicines.
• Related Government Initiatives:
  • Production Linked Incentive (PLI) Scheme for Pharmaceuticals
  • Promotion of Bulk Drug Parks Scheme
  • Strengthening Pharmaceuticals Industry Scheme

What Steps Can be Taken to Reform India’s Pharma Sector?

• Legislative Changes and Centralised Database:
  • Drugs and Cosmetics Act (1940) needs to be amended and the establishment of a centralised drugs database can enhance surveillance and ensure effective regulation across all manufacturers.
  • India has 36 regional drug regulators; consolidating them into a single entity can reduce the risk of regulatory capture and influence networks.
  • Also, implementing common quality standards across all states is necessary to ensure consistent product quality.
• Encouraging Certification:
  • Encouraging more pharmaceutical manufacturing units to obtain WHO's Good Manufacturing Practice certification can elevate industry-wide quality standards.
• Transparency, Credibility, and Accountability:
  • The regulator and the industry must collaborate to enhance India's drug regulatory regime, making it transparent, credible, and aligned with global standards.
    • Public disclosure of drug application reviews and inspection records, violation history can ensure accountability.
  • The cancellation of manufacturing licences for 18 pharma companies by the Drugs Controller General of India (DGCI) is a positive step.
  • However, more comprehensive measures are required to address the root causes of quality issues.
• Focus on Sustainable Manufacturing Practices:
  • Emphasising sustainable manufacturing practices, including green chemistry, waste reduction, and energy efficiency, can enhance the sector's environmental sustainability while reducing costs.
    • Adopting environmentally friendly practices can also contribute to a positive brand image and attract environmentally conscious consumers.

UPSC Civil Services Examination, Previous Year Question (PYQ):

Mains:

Q. How is the Government of India protecting traditional knowledge of medicine from patenting by pharmaceutical companies? (2019)

Source: IE