Context:
Union Budget 2024-25 has proposed removing the 10-12% customs duty on three cancer medicines marketed by AstraZeneca.
Indian Pharmaceutical Industry:
- Known as ‘the pharmacy of the world’
- Production – Ranks 3rd globally by volume and 14th by value.
- Largest provider of generic medicines, with a 20% global share.
- Leading vaccine manufacturer, supplying 62% of the world’s vaccines and 70% of WHO’s essential vaccines.
- FDI Policies –
- Greenfield Pharmaceuticals – 100% FDI allowed under the automatic route.
- Brownfield Pharmaceuticals – 100% FDI allowed, with 74% under the automatic route and the remainder through government approval.
- Exports – Supplies over 50% of Africa’s requirement for generics, ~40% of generic demand in the US and ~25% of all medicine in the UK.
Central Drugs Standard Control Organisation (CDSCO):
- India’s national regulatory authority for pharmaceuticals, medical devices, and cosmetics.
- Operates under – Directorate General of Health Services, Ministry of Health & Family Welfare
- Headquarters – New Delhi.
- Comprises 6 zonal offices and 7 laboratories across the country.
- Key Functions –
- Drug Approval – Responsible for the approval of new drugs and clinical trials.
- Standards and Quality Control – Lays down standards for drugs and ensures the quality of imported drugs.
- Licensing – Along with state regulators, grants licenses for critical drugs such as blood products, vaccines, and intravenous fluids.
- Regulation – Ensures the safety, efficacy, and quality of medical products manufactured, imported, and distributed in India
- SUGAM Portal – Initiative of CDSCO facilitating online applications for manufacturing, importing, and conducting clinical trials.
- Also provides a platform for manufacturers to add their formulations data and request vaccine sample testing.
Read more about: Pharma Imports, Revamped Pharmaceuticals Technology Upgradation Assistance Scheme (RPTUAS), Indian Pharmacopoeia Commission (IPC), National Policy on Research and Development and Innovation in Pharma-MedTech
Source: The Hindu
Previous Year Question
With reference to the provisions made under the National Food Security Act, 2013, consider the following statements:
1. The families coming under the category of ‘below poverty line (BPL)’ only are eligible to receive subsidised food grains.
2. The eldest woman in a household, of age 18 years or above, shall be the head of the household for the purpose of issuance of a ration card.
3. Pregnant women and lactating mothers are entitled to a ‘take-home ration’ of 1600 calories per day during pregnancy and for six months thereafter.
Which of the statements given above is/are correct?
[UPSC Civil Services Exam – 2018 Prelims]
(a) 1 and 2 only
(b) 2 only
(c) 1 and 3 only
(d) 3 only
Answer: (b)
Explanation:
Statement 1 is not correct:
The Act provides for coverage of up to 75% of the rural population and up to 50% of the urban population.
Statement 3 is not correct:
Pregnant women and lactating mothers are entitled to a ‘take-home ration’ of 600 calories per day during pregnancy and for six months thereafter.
