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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 to 30 June 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. 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)

Show history (2 other updates)
  1. 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)

  2. 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)

The PCPNDT Act and the child sex ratio

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Prelims and Mains

The Pre Conception and Pre Natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994, amended in 2002 and 2013, prohibits sex selection before or after conception and limits prenatal diagnostic techniques to detecting abnormalities or metabolic disorders.

  • Ultrasound clinics must register and keep a Form F for each pregnant woman scanned; violations can bring cancellation of registration and up to five years in jail.
  • Many countries allow prenatal sex determination but ban sex selective abortion; India bans both.

Child sex ratio by census

  1. 1994

    The Act is passed

  2. 2002

    The Act is amended

  3. 2011

    Child sex ratio of 919

  4. 2013

    The Act is amended again

The child sex ratio kept falling for two decades after the Act, which is why the courts read its record keeping rules strictly.Source: The Indian Express, 15 June 2026

What changed

  1. 15 Jun 2026New

    • On 11 June the Supreme Court dismissed a Nanded doctor's plea to quash PCPNDT proceedings over incomplete Form F records, holding the Act leaves no room for errors in record keeping.
    • The court noted the child sex ratio fell to 919 in 2011, with a recent recovery at birth, a partial course correction.

    Mains: Strict enforcement remains essential until social attitudes change, alongside schemes such as Beti Bachao Beti Padhao.

    The Indian Express, 15 Jun 2026: Falling child sex ratio, systemic bias: Why India banned checking a baby's sex in the womb (opens in a new tab)

Cough syrups and Schedule K

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Prelims and Mains

LeadRegulating medicines: cough syrups, fixed dose combinations and QR codesJune 2026

Why in news

In June 2026 the Health Ministry announced four changes to how medicines are regulated: cough syrups may be sold only by licensed pharmacies, sixteen fixed dose combinations were banned, QR codes were notified for vaccines, antimicrobials and cancer drugs from 2027 and 2028, and minor offences under the health laws were decriminalised.

Background

  • Medicines are regulated under the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945.
  • The Central Drugs Standard Control Organisation (CDSCO) approves new drugs; State drug controllers license manufacture and sale.
  • The Drugs Technical Advisory Board (DTAB) advises the government on technical matters.
  • The Rules carry Schedules that sort drugs: Schedule H drugs need a prescription; Schedule K lists exemptions.
  • In October 2025 at least 20 children in Madhya Pradesh died after taking a cough syrup adulterated with diethylene glycol, an industrial solvent.

1. Cough syrups: Schedule K

  • Schedule K exempts named classes of drugs from parts of the Act. One entry had let cough syrups be sold in small villages without a retail licence.
  • The word "syrup" has been removed from that entry, so cough syrups may be sold only through licensed pharmacies, on a doctor's prescription; lozenges, pills and tablets stay exempt.
  • Critics call it defensive: the deaths came from failures in manufacturing and in testing raw material, not from where the syrup was sold.

2. Fixed dose combinations

  • A fixed dose combination (FDC) holds two or more active drugs in fixed proportions in one dose.
  • It is rational only if each drug adds to the effect. An irrational FDC exposes the patient to needless drugs, and in antibiotics it breeds resistance.
  • Sixteen FDCs were banned under Section 26A of the Act, after an expert committee found them irrational.

3. QR codes: Schedule H2

  • Schedule H2 requires a bar code or QR code on the label, so that each pack can be traced from factory to shop.
  • It first covered the top 300 brands. It now covers all vaccines, anti cancer drugs and narcotic and psychotropic drugs from July 2027, and antimicrobials from July 2028.
  • The shift is from regulating by sales to regulating by risk.

4. Jan Vishwas: decriminalising minor lapses

  • The Jan Vishwas (Amendment of Provisions) Act, 2026 turns minor procedural offences in many laws into administrative penalties.
  • In the health laws, lapses in paperwork now draw a penalty after a hearing, while offences that endanger health stay criminal.

The way forward

  • Strengthen State drug controllers, who are understaffed, since rules made at the Centre are enforced in the States.
  • Test raw materials and finished batches, which is where the cough syrup deaths began.
  • Make traceability work through real time State databases that work across States, and habitual scanning by pharmacists.
  • Enforce bans at the pharmacy counter, where banned stocks have kept selling in the past.

Prelims facts

  • A drug can be banned in the public interest under Section 26A of the Drugs and Cosmetics Act, 1940.
  • Schedule H2 concerns QR codes; Schedule K concerns exemptions.
  • DTAB is the Drugs Technical Advisory Board.
  • Diethylene glycol and ethylene glycol are the contaminants tested for in oral liquids.

Open the lead on its own page

Schedule K of the Drugs Rules, 1945 exempts named classes of drugs from certain provisions of the Drugs and Cosmetics Act, 1940. Entry 13 had allowed cough syrups to be sold in villages of fewer than 1,000 people without retail licensing. Diethylene glycol and ethylene glycol are industrial solvents and antifreeze agents, fatal even in small amounts, which enter medicines through adulterated excipients such as glycerin, propylene glycol, sorbitol and polyethylene glycol; the Indian Pharmacopoeia mandates tests for them in all oral liquids, but State drug controllers are understaffed. The same schedule's exemption was withdrawn in July 2026 for formulations with more than 12 per cent alcohol in packs above 30 ml, tinctures that were being diverted for intoxication, which moved to Schedule H1 and prescription only sale.

Syrup deaths to the rule

  1. October 2022

    WHO alert on contaminated syrups: The Gambia

  2. November 2022

    WHO alert: Indonesia

  3. January 2023

    WHO alert: Uzbekistan; WHO reports over 300 deaths, mostly children under five

  4. October 2025

    At least 20 children die in Madhya Pradesh after taking Coldrif syrup

  5. December 2025

    Amendment to Schedule K issued

  6. 16 June 2026

    Rule in force: cough syrups only through licensed pharmacies

The rule came after a run of deaths from diethylene glycol in syrups at home and abroad.Source: The Hindu, 23 June 2026; PIB, 16 June 2026

What changed

  1. 25 Jun 2026LeadRegulating medicines: cough syrups, fixed dose combinations and QR codes

See also: Indian Pharmacopoeia Commission

Prelims and Mains

A virtual autopsy, or virtopsy, examines a body with computed tomography (CT) and magnetic resonance imaging (MRI) instead of extensive dissection.

  • Whole body CT finds brain haemorrhage, internal bleeding and fractures within minutes.
  • It leaves a permanent digital record and preserves bodily integrity, which families often prefer.
  • The All India Institute of Medical Sciences (AIIMS), Delhi has a Centre for Advanced Research and Excellence in Virtual Autopsy.

What changed

  1. 29 Jun 2026BriefForensic experts propose Virtopsy Centres in major medical colleges and a national digital grid of post mortem repositories, to ease overcrowded mortuaries and delays in releasing bodies. Mains: Virtopsy reconciles the legal need for evidence with the humanitarian duty to return bodies quickly and with dignity. The Indian Express, 29 Jun 2026: Experts Explain | How virtual autopsies can aid both medico-legal processes and grieving families (opens in a new tab)

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