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IPC Releases Enoxaparin Sodium Reference Substance at National Biosimilars Conference — UPSC Current Affairs 2026

Science & Tech11 Sept 2026

IPC Releases Enoxaparin Sodium Reference Substance at National Biosimilars Conference

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The Indian Pharmacopoeia Commission held a two-day National Conference on the quality and safety of biosimilars on 10-11 September 2026 at C-CAMP, Bengaluru, with 160 participants from regulators, industry, academia and research bodies.
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Its main output was the release of an Indian Pharmacopoeia Reference Substance for enoxaparin sodium for bioassays, an authenticated reference material for testing the drug's biological activity.
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The conference was framed around the government's Biopharma SHAKTI vision and organised with IDMA, with BIRAC and C-CAMP as knowledge partners and KDPMA as associate partner.

●The Indian Pharmacopoeia Commission (IPC) is an autonomous body under the Ministry of Health and Family Welfare, fully financed by the Centre, headquartered at Ghaziabad, Uttar Pradesh, and operational from 1 January 2009. Dr V. Kalaiselvan is its Secretary-cum-Scientific Director.
●IPC publishes the Indian Pharmacopoeia, the country's official book of drug standards, legally recognised under the Drugs and Cosmetics Act, 1940. The current edition, IP 2026, is the 10th, was released on 2 January 2026 and carries 3,340 monographs after 121 new additions.
●Indian Pharmacopoeia Reference Substances are the authenticated materials laboratories test drug batches against. The new one is for enoxaparin sodium, a low-molecular-weight heparin used as an anticoagulant to prevent and treat thromboembolic disorders, and it supports bioassay measurement of its biological activity.
●A biosimilar, termed a 'similar biologic' in Indian regulation, is a biological product similar in quality, safety and efficacy to an approved reference biological product. India's Guidelines on Similar Biologics were issued jointly by CDSCO and the Department of Biotechnology in 2012 and revised in 2016.
●The Central Drugs Standard Control Organisation (CDSCO), under the Ministry of Health and Family Welfare and headed by the Drugs Controller General of India, is the national regulator for drugs, cosmetics and medical devices; it is headquartered in New Delhi and functions under the Drugs and Cosmetics Act, 1940.
●IPC is also the National Coordination Centre for the Pharmacovigilance Programme of India, launched in July 2010 to monitor adverse drug reactions.
●The venue, the Centre for Cellular and Molecular Platforms (C-CAMP), is a Department of Biotechnology-backed life-sciences innovation and incubation hub set up at Bengaluru in 2010; BIRAC, the other knowledge partner, is the DBT's biotechnology industry funding arm.
●Biopharma SHAKTI, the vision the conference was aligned to, is a Department of Pharmaceuticals initiative announced with an outlay of about Rs 10,000 crore over five years from FY 2026-27, aimed at moving India from generics to high-value biologics and biosimilars.

Exam Relevance

upsc

GS Paper 2 > Governance > Health; GS Paper 3 > Science and Technology > Biotechnology

Expected Questions

★UPSC may test the difference between a generic drug and a biosimilar, or ask which body maintains the Indian Pharmacopoeia and under which Act it is recognised.

Key Terms

Biosimilar (similar biologic)

A biological medicine shown to be similar in quality, safety and efficacy to an already approved reference biologic; unlike a chemical generic it can never be an identical copy, which is why comparability and immunogenicity testing are required.

Reference substance (IPRS)

An authenticated material of known quality issued by the pharmacopoeial authority, against which laboratories calibrate tests of a drug's identity, purity or biological activity.

priority_highMust Remember

•IPC: autonomous body under MoHFW, Ghaziabad, operational 1 January 2009; also the National Coordination Centre for the Pharmacovigilance Programme of India, launched July 2010.
•Indian Pharmacopoeia 2026 is the 10th edition, released 2 January 2026, with 3,340 monographs; the IP is recognised under the Drugs and Cosmetics Act, 1940.
•CDSCO, headed by the DCGI, is the regulator; IPC is the standard-setter. Regulator and pharmacopoeial authority are distinct bodies and are commonly swapped in options.

tips_and_updatesExam Tips

•Enoxaparin sodium is worth remembering as a low-molecular-weight heparin: anticoagulant drug classes turn up in prelims science questions and in banking general-awareness health items alike.

Question 1 of 2Score: 0/0

Factual

Which body functions as the National Coordination Centre for the Pharmacovigilance Programme of India?

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Current Affairs Pulse

IPC Releases Enoxaparin Sodium Reference Substance at National Biosimilars Conference

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Exam Relevance

Expected Questions

Key Terms

priority_highMust Remember

tips_and_updatesExam Tips

Practice Quiz

Which body functions as the National Coordination Centre for the Pharmacovigilance Programme of India?

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