India Pharma Products and Drug Safety

Context:

Recently, deaths of two patients in Sri Lanka happened because of administration of Indian-made anesthetic drugs. 

The Series of Adverse Reports Against Indian Produced Drugs:

• Eye Drop Issue: Manufactured eye drops caused eye infection in about 30 patients and blindness in 10 in Sri Lanka.
  • Indian manufactured eye drops causing infections, blindness and even deaths were reported in the United States. 
• Cough Syrup Issue: The World Health Organization (WHO) linked the deaths of at least 70 children in Gambia from acute kidney injury to Indian-made cough syrups. 
  • Indian-made cough syrups killed 18 children in Uzbekistan in December 2022. 
  • In end-April this year, Indian-made cough syrup was again in the news when WHO flagged the contaminated drugs found in the Marshall Islands and Micronesia.

Status of India’s Pharmaceutical Industry:

• India is the largest manufacturer of generic medicines globally. 
• India is known as the Pharmacy of the World.
• India’s pharmaceutical industry plays a crucial role in global healthcare, providing affordable generic medicines.
• Currently, it is valued at USD 50bn and expected to be USD 65bn by 2024 and to USD 130bn by 2030.

Challenges of India’s Pharmaceutical Industry:

• Quality Failures & Global Reputation: Various infections and deaths related incidents are a big question mark on India’s Pharmaceutical industries.
• Violation of Intellectual Property Rights Rules: Indian pharmaceutical companies are facing various legal disputes with multinational pharmaceutical companies.
• Pricing Issue: While India’s manufactured generic drugs have contributed to affordable healthcare globally, the pricing of pharmaceuticals remains a significant concern. 
• Access: Access to healthcare is a significant challenge.
• Infrastructure: Inadequate healthcare infrastructure and uneven distribution of healthcare facilities are other concerning issues.
• Non-effective regulatory framework: Despite having various regulatory bodies, regulatory frameworks are non-effective.
• Transparency & Credibility: Lack of public disclosures are the main reasons for lack of transparency & credibility in India’s Pharmaceutical Industry.
• Environmental Sustainability: Non-existence of waste reduction measures and lacking focus on Green Chemistry implementation are challenges to the environment.

Steps Taken by the Indian Government:

• Production Linked Incentive (PLI) Scheme: For promotion of Domestic Manufacturing of Critical Key Starting Materials (KSMs)/ Drug Intermediates and Active Pharmaceutical Ingredients (APIs) in the Country.
  • Tenure of the Production Linked Incentive Scheme is FY 2020-21 to FY 2029-30. 
  • Base year of the scheme is FY 2019-20.
  • In a bid to make the pharmaceutical sector self-reliant, India has started the production of 22 active pharmaceutical ingredients (API) or bulk drugs used for the manufacturing of life-saving drugs and high-end medical devices like CT scan and MRI machines, under the Production Linked Incentive (PLI) scheme.
• The Scheme for Promotion of Bulk Drug Parks: It was approved by the Government of India in March 2020 to drastically reduce the cost of manufacturing bulk drugs, which will increase the competitiveness of the domestic bulk drug industry in India.
• Strengthening of Pharmaceutical Industry (SPI): The Scheme is implemented by the Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers with a financial outlay of ₹ 500 crores and tenure from FY 2021-2022 to FY 2025-26. 
• The scheme has three sub-schemes:
  • • Assistance to Pharmaceutical Industry for Common Facilities (APICF) to provide infrastructure support for pharma MSMEs clusters for strengthening the infrastructure facilities
    • Promotion of Technology Upgradation Assistance Scheme (PTUAS) to address the issues of technology upgradation of individual pharma MSMEs 
    • Pharmaceutical and Medical Device Promotion and Development Scheme (PMPDS) to create awareness, conduct surveys, studies, organize seminars, events.

Steps Need to be Taken:

• Regulation: Need for regulation of Drug Regulatory Bodies with emphasis on Centralised Regulatory Data.
• Punishment: Strict Punishments should be imposed on non-compliances.
• Collaboration: Time to collaborate with international organizations and Encouraging more pharmaceutical units to obtain WHO’s Good Manufacturing Practice certification, which can help in gaining quality standards and global trust.
• Transparency, Credibility and Accountability: These are the need of the hour which could be gained by maintaining Public disclosure of drug application reviews and inspection records and violation history can ensure accountability.
• Environmental Sustainability: Time to focus on Sustainable Manufacturing Practices by including green chemistry, waste reduction and energy efficiency.

Conclusion:

India can continue to be the pharmacy of the global south & the World only if the regulator begins to behave like a watchdog to ensure drug safety, and not as a facilitator for the pharma industry. India’s drug regulators must ensure quality and safety of drugs. 

News Source: The Hindu