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हिन्दी — Read in HindiDrugs, 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
All 10 articles shown; the 2 that changed from 1 to 31 July 2026 are marked.Show only these
Indian Pharmacopoeia Commission
Copy link to Indian Pharmacopoeia CommissionPrelims
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.
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
What changed
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.
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)
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
Copy link to Central licensing of cell and gene therapiesPrelims 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
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
Copy link to Drones for tuberculosis samplesPrelims 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
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)
The PCPNDT Act and the child sex ratio
Copy link to The PCPNDT Act and the child sex ratioPrelims 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
1994
The Act is passed
2002
The Act is amended
2011
Child sex ratio of 919
2013
The Act is amended again
What changed
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.
Cough syrups and Schedule K
Copy link to Cough syrups and Schedule KPrelims 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.
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
October 2022
WHO alert on contaminated syrups: The Gambia
November 2022
WHO alert: Indonesia
January 2023
WHO alert: Uzbekistan; WHO reports over 300 deaths, mostly children under five
October 2025
At least 20 children die in Madhya Pradesh after taking Coldrif syrup
December 2025
Amendment to Schedule K issued
16 June 2026
Rule in force: cough syrups only through licensed pharmacies
What changed
See also: Indian Pharmacopoeia Commission
Fixed dose combinations: the 2026 ban
Copy link to Fixed dose combinations: the 2026 banPrelims and Mains
A fixed dose combination (FDC) holds two or more active drugs in fixed proportions in one dosage form. It is rational only if each component adds to the effect, the drugs are compatible and the combination beats the separate medicines clinically. Irrational FDCs expose patients to needless drugs, interactions and allergies, stop doctors adjusting one ingredient's dose, and in antibiotics create selective pressure for resistant bacteria; steroid plus antifungal creams can worsen fungal infection. Section 26A of the Drugs and Cosmetics Act, 1940 lets the Centre prohibit a drug in the public interest when it lacks therapeutic justification or its risks outweigh its benefit, and State Drug Controllers enforce the ban.
FDC bans
March 2016
344 FDCs banned
2017
Supreme Court directs a review by the Drugs Technical Advisory Board
September 2018
328 re banned and six restricted
2024
156 more banned
June 2026
16 banned with immediate effect
Schedule H2: QR codes on medicines
Copy link to Schedule H2: QR codes on medicinesPrelims and Mains
Schedule H2 of the Drugs Rules, 1945, first applied to the top 300 pharmaceutical brands, requires a bar code or Quick Response (QR) code on the primary label (or the secondary label if space is short) carrying nine data elements: unique product identifier, proper and generic name, brand, manufacturer's name and address, batch number, manufacture and expiry dates, licence number and excipients. Manufacturers, wholesalers and retailers log each unit on track and trace platforms, so a code cannot be re registered, which defeats refilled vials; tracing also shows where contamination arose and eases recalls. Substandard antimicrobials cause sub therapeutic dosing that selects for resistant strains.
QR traceability
Before 2026
Schedule H2 created for the top 300 brands, about four years before the 2026 notification
22 June 2026
Gazette notification extends Schedule H2
1 July 2027
Vaccines, NDPS drugs and anti cancer drugs must comply
1 July 2028
Antimicrobials must comply
Jan Vishwas 2026 in the health laws
Copy link to Jan Vishwas 2026 in the health lawsPrelims and Mains
The Jan Vishwas (Amendment of Provisions) Act, 2026, gazetted on 8 April 2026, amends provisions across 79 Central Acts of 23 ministries, 35 of them in five health Acts. It moves minor procedural lapses from criminal prosecution to administrative adjudication, with a hearing before any penalty, recovery mechanisms and an appeal route, while offences that endanger public health stay criminal; it implements the High Level Committee on Regulatory Reforms' recommendations.
Provision, old treatment, new treatment
| Provision | Old treatment | New treatment |
|---|---|---|
| Drugs and Cosmetics Act, Section 29: using a Government Analyst's report in advertising | penal provision | omitted |
| Drugs and Cosmetics Act, Section 28A: procedural violations | criminal | administrative penalty |
| Low risk cosmetic lapses | criminal | administrative penalty |
| Food Safety and Standards Act: interfering with seized items | imprisonment up to six months | imprisonment up to three months |
| Food Safety and Standards Act: obstructing a Food Safety Officer | offence under the Act | dropped, as covered by the Bharatiya Nyaya Sanhita |
Virtual autopsy
Copy link to Virtual autopsyPrelims 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
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)
Rare diseases and orphan drugs
Copy link to Rare diseases and orphan drugsPrelims 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
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.