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Drugs, diagnostics and medical technology

Drug approval and trials, the pharmacopoeia, substandard medicines, generics, prices, devices and pharmacovigilance. It serves GS3 answers on science and technology in health.

Foundation note: Who regulates medicines in India, and the drug schedules

Showing 4 of 10 articles, those that changed from 1 July to 30 September 2026.Show all

Indian Pharmacopoeia Commission

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Prelims

A pharmacopoeia is the official book of standards a medicine must meet for identity, purity and strength, and India's is written by the Indian Pharmacopoeia Commission (IPC).

  • Setting those standards is one half of the Commission's work; the other is watching what medicines and devices do once they are in use.
Indian Pharmacopoeia Commission
  • Works under

    • Ministry of Health and Family Welfare
  • Publishes

    • The Indian Pharmacopoeia, the official drug standards under the Drugs and Cosmetics Act, 1940
  • Runs

    • Pharmacovigilance Programme of India
    • Materiovigilance Programme of India
From the Press Information Bureau (PIB) releases of 4 August and 11 September 2026

What changed

  1. 4 Aug 2026BriefThe WHO South East Asia Regulatory Network (SEARN) named the IPC its Regional Centre of Excellence in Pharmacovigilance. The IPC is also the network's Technical Centre in Quality of Medicines. PIB, 4 Aug 2026: Indian Pharmacopoeia Commission named WHO-SEARN Centre of Excellence (opens in a new tab)

  2. 21 Sep 2026

    • A Biovigilance Programme of India, led by the Commission, will track adverse events from products used in organ and tissue transplantation.
    • It is the third safety track, after pharmacovigilance for medicines and materiovigilance for medical devices.

    PIB, 21 Sep 2026: Union MoS for Health and Family Welfare Smt. Anupriya Patel launches 7th National Formulary of India 2026, announces Biovigilance Programme to widen India’s patient-safety net (opens in a new tab)

Show history (1 other update)
  1. 24 Jun 2026BriefAmendment List 09 to IP 2022, in force from 10 October 2025, mandates the test for ethylene glycol and diethylene glycol in all oral liquid formulations. IP 2026 is the first pharmacopoeia with dedicated monographs for blood and blood components. PIB, 24 Jun 2026: IPC Successfully Conducts 2nd Hands-on Training on Ethylene Glycol (EG) and Diethylene Glycol (DEG) Determination in Oral Liquid Preparations by Gas Chromatography (opens in a new tab) · PIB, 24 Jun 2026: IPC Organizes National Conference on Ensuring Quality of Blood and Blood Components through IP 2026 Standards (opens in a new tab)

Central licensing of cell and gene therapies

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Prelims and Mains

Stem cell products, gene therapies and xenografts are licensed jointly by the central and State drug regulators under the Drugs Rules, 1945, as vaccines and recombinant medicines already are.

  • This closes the route by which clinics sold unproven stem cell cures.

What changed

  1. 3 Jul 2026New

    • The Drugs Rules, 1945 were amended to bring stem cell products, gene therapies and xenografts under joint central and state licensing, as vaccines and recombinant DNA medicines already are.
    • The amendment approves no therapy. Its practical target is clinics selling unproven stem cell cures.
    • It covers CAR-T therapy, in which a patient's own T cells are engineered to attack cancer, and animal tissue products such as heart valves.

    The Indian Express, 3 Jul 2026: Stem cell products, gene therapies and xenografts brought under central licensing (opens in a new tab) · PIB, 2 Jul 2026: Centre Expands Centrally License Approving Authority (CLAA) Framework to Include Cell and Stem Cell-derived Products, Gene Therapeutics and Xenografts (opens in a new tab) · The Hindu, 4 Jul 2026: Central licensing net to cover stem cell, gene therapies (opens in a new tab)

Drones for tuberculosis samples

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Prelims and Mains

i-DRONE is the Indian Council of Medical Research's programme for carrying medical samples and supplies by drone, tested for tuberculosis sputum samples in Telangana.

What changed

  1. 12 Jul 2026BriefA study under the i-DRONE initiative in Yadadri Bhuvanagiri district of Telangana flew sputum samples from health centres to laboratories. Diagnosis time fell from 15 days to 5, and the patient's average cost fell too. The Hindu, 12 Jul 2026: Drones move TB samples, cut diagnosis costs from ₹9,451 to ₹91 in new ICMR trial (opens in a new tab) · PIB, 16 Jul 2026: Research under the ICMR’s i-DRONE initiative demonstrates the potential of drone technology to strengthen access to TB diagnostic services in difficult-to-reach areas (opens in a new tab)

Rare diseases and orphan drugs

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Prelims and Mains

An orphan drug is a medicine for a rare disease, long neglected by drug makers because the market for it is small.

  • Government support for a patient with a rare disease is capped at ₹50 lakh, and there is a government crowdfunding platform for patients.
  • The drug regulator may waive a local clinical trial for a drug already approved in certain other countries.

What changed

  1. 29 Sep 2026New

    • India has reported about 1,000 rare genetic disorders, and drugs exist for only about 5 per cent of rare diseases.

    Mains: incentives for manufacture, advance purchase commitments and pricing that shares benefits could make India a base for affordable orphan drugs.

    The Hindu, 29 Sep 2026: Why rare-disease drugs could become India’s next pharma frontier (opens in a new tab)

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