GS Paper 3
Syllabus: Industrial Growth/ Governance
Source: IE
Context: The article emphasizes the need to improve India’s drug regulatory regime to ensure credibility in the pharmaceutical industry.
Status of India’s pharmaceutical industry:
| Generic medicines | India is the largest manufacturer of generic medicines globally (valued at US$50bn currently and expected to reach US$130 Bn by 2030)
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| India’s ranking in production | Indian Pharma ranks third in pharmaceutical production by volume. India is often referred to as the ‘pharmacy of the world’
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| Vaccine supplier | India is the largest vaccine supplier in the world by volume (over 50% of all vaccines manufactured in the world)
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| Major pharmaceutical hubs in India | Vadodara, Ahmedabad, Ankleshwar, Vapi, Baddi, Sikkim, Kolkata, Visakhapatnam, Hyderabad, Bangalore, Chennai, Margao, Navi Mumbai, Mumbai, Pune and Aurangabad, Pithampur.
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Various issues associated with regulating the pharmaceutical industry in India:
| Issues | Description | Example |
| Quality control failures | Instances of contaminated medicines and substandard drugs raise concerns about product safety. | Contaminated medicine causing deaths in Gambia or Uzbekistan (2022) |
| Intellectual Property Rights (IPR) | Allegations of violating IPR laws | Patent infringement case between Roche and Cipla. |
| Pricing and affordability | Challenges in balancing the need for affordable medicines for the poor with the profitability of pharmaceutical companies. | Concerns by pharma companies overpricing of drugs within
National List of Essential Medicines (NLEM) |
| Healthcare infrastructure and access | Issues related to inadequate healthcare infrastructure, uneven distribution of facilities, and low insurance coverage. | Limited access to healthcare in rural areas of the country. |
| Global reputation | Maintaining a strong global reputation as a reliable supplier of high-quality pharmaceutical products. | Global Pharma Healthcare had to recall a batch of eye drops exported to the US due to links with vision loss (Feb 2021) |
| Regulatory framework | India has 36 drug regulatory bodies causing confusion and non-effective enforcement of regulations. | |
| Transparency and credibility | Lack of public disclosure of drug application reviews. | |
| Environmental sustainability | E.g., Implementing green chemistry and waste reduction measures has been found to be non-existent. | |
In India, drugs and cosmetics are regulated by:
- Act: Drugs and Cosmetics Act, 1940 and Rules 1945: It assigns various responsibilities to central and state regulators.
- Agencies:
- Drugs Controller General of India (DCGI): It is responsible for approving licenses for specified categories of drugs, setting standards for manufacturing, sales, import, and distribution of drugs in India, and heads the department of CDSCO.
- Central Drugs Standard Control Organisation (CDSCO): It prescribes standards for ensuring the safety, efficacy, and quality of drugs, cosmetics, diagnostics, and devices. It also regulates the market authorization of new drugs and clinical trial standards.
- National Pharmaceutical Pricing Authority (NPPA): It controls the pricing of pharmaceutical drugs in India
Steps that can be taken by the government:
| Steps | Description |
| Amend the Drugs and Cosmetics Act (1940) | Modify the existing legislation to align it with current requirements and enhance regulatory oversight. |
| Create a centralized drug database | Establish a comprehensive database to facilitate effective surveillance of all pharmaceutical manufacturers. |
| Merge India’s 36 regional regulators | Consolidate the regional regulatory authorities into a unified entity to streamline the regulatory process and reduce the risk of inconsistent enforcement. |
| Set common quality standards across states | Implement uniform quality standards across all states to ensure consistent product quality and reduce the risk of varying regulatory enforcement. |
| Increase budgetary support | Allocate additional funds to strengthen inspection teams and conduct more frequent inspections related to product quality. |
| Impose clear penalties for firms exporting spurious drugs | Establish strict penalties for companies involved in exporting counterfeit or substandard drugs. This will deter such practices and safeguard public health. |
| Create a public database of safety data | Develop a comprehensive safety database that contains information on drug-related adverse events, side effects, and other safety concerns. |
| Enact a national law on drug recall | This will ensure swift and effective recall processes, protecting the public from potentially harmful drugs. |
| Strengthen CDSCO | Strengthen the Central Drugs Standard Control Organisation (CDSCO) and provide it with statutory backing |
| WHO’s Good Manufacturing Practice certification | Promote and incentivize pharmaceutical manufacturers to adhere to the WHO’s Good Manufacturing Practice (GMP) standards. |
Conclusion:
Indian government can enhance the quality and regulation of the pharmaceutical industry through legislative amendments, centralized drug databases, and the merging of regulators. It will build confidence, ensure high-quality generics, and uphold India’s reputation as a reliable supplier, benefiting both domestic and global healthcare while protecting public health.
Insta Links:
Spurious Drug Menace
Mains Links:
India enjoys an important position in the global pharmaceuticals sector. Analyse the strength and weaknesses of India in this sector. Suggest steps to overcome the weaknesses. (250 Words)
