Indian Pharmacopoeia Commission

India’s official book of drug standards has its own dedicated commission behind it. This article covers the Indian Pharmacopoeia Commission: its mandate, its two vigilance programmes, and its 2026 international recognition.

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General Science · GenSci0026

India’s drug-standards body, Ghaziabad

2009

Constituted as an autonomous institution

2010

Launches PvPI, the drug-safety programme

2015

Launches MvPI, the medical-device programme

Aug 2026

Named WHO-SEARN’s regional centre of excellence

📑 Contents

1Must Know
2Good to Know
3Test Yourself
4Great to Know
5Current Affairs

Must Know

The Indian Pharmacopoeia Commission (IPC) is an autonomous institution under the Ministry of Health and Family Welfare. It is headquartered in Ghaziabad, Uttar Pradesh.
IPC was constituted in its present autonomous form in 2009. Its roots trace back to 1956, when the Government of India first set up a body by executive order.
IPC publishes the Indian Pharmacopoeia, India’s official book of drug standards. It sets the identity, purity, strength, and quality benchmarks for medicines under the Drugs and Cosmetics Act, 1940.
IPC coordinates two national vigilance programmes. The Pharmacovigilance Programme of India (PvPI) monitors adverse drug reactions. The Materiovigilance Programme of India (MvPI) monitors adverse events linked to medical devices.

Good to Know

PvPI launched in 2010. MvPI followed in 2015, launched by the Drugs Controller General of India.
IPC also develops Indian Pharmacopoeia Reference Substances (IPRS) and Impurity Reference Standards (IMPRS), used to test drug quality against a known benchmark.
Work on India’s first pharmacopoeia began in 1944, under the chairmanship of Col. R.N. Chopra. The first edition was published in 1946.

Test Yourself

Great to Know

IPC’s dual vigilance role, covering both drugs (PvPI) and medical devices (MvPI), reflects a broader shift in drug regulation. Modern pharmacovigilance now tracks safety across the full product lifecycle, not just at the approval stage.
Reference standards like IPRS and IMPRS matter because a drug’s quality claim is only as good as the benchmark it is tested against. IPC’s role in setting those benchmarks makes it central to India’s entire drug-quality assurance system, even though it rarely appears in public discussion.

Current Affairs

On 4-5 August 2026, IPC took part in the 10th Anniversary Meeting of the South-East Asia Regulatory Network (SEARN), in Kathmandu, Nepal. (Source: PIB)
SEARN is a WHO South-East Asia Regional Office (SEARO) platform, set up in 2016 to strengthen drug-regulatory systems across the region.
At the meeting, IPC was named WHO-SEARN’s Regional Centre of Excellence in Pharmacovigilance and its Technical Centre in Quality of Medicines. The recognition covers the full South-East Asia Region.
On 23 July 2026, IPC signed two fresh MoUs, under the “Viksit UP – Viksit Bharat” vision. One renews ties with CSIR-CIMAP, on medicinal-plant research and herbal-medicine quality standards. (Source: PIB)
The other is new, with Dr. Shakuntala Misra National Rehabilitation University, Lucknow. It covers quality assessment for assistive devices used by persons with disabilities. (Source: PIB)
It also supports a pharmacovigilance training module in sign language, to help persons with disabilities report adverse drug reactions more easily. (Source: PIB)
On 15 July 2026, IPC signed an MoU with the Uttar Pradesh Promote Pharma Council (UPPPC), at the YEIDA MedTech Investors Meet, Greater Noida. (Source: PIB)
The partnership covers pharmacovigilance awareness, joint training programmes, and digital adverse-event reporting tools for MSMEs. It aims to strengthen Uttar Pradesh’s pharma and medical-device sector. (Source: PIB)
10 July 2026: The government amended the Drugs Rules, 1945, again — this time targeting high alcohol-content formulations, a separate change from the 2 July cell/gene-therapy amendment below. Some products, like certain aromatic tinctures, held ethyl alcohol content as high as 80-90% v/v, and had been exempt from licensing. That exemption made them prone to misuse, for intoxication. (Source: PIB)
Now, formulations with more than 12% v/v ethyl alcohol, in quantities over 30 mL, lose that exemption. They move from Schedule K to the stricter Schedule H1. Schedule H1 requires a doctor’s prescription, and tighter record-keeping. (Source: PIB)
2 July 2026: The Central Government amended the Drugs Rules, 1945, with effect from 29 June 2026, via the Drugs (Eighth Amendment) Rules, 2026. The change brings three new product categories under the Centrally License Approving Authority (CLAA) framework. (Source: Civilsdaily)
The three categories are Cell or Stem Cell-derived products, Gene therapeutic products, and Xenografts. CAR-T cell therapy, used against blood cancers like leukemias and lymphomas, is one example.
Gene therapeutic products cover gene replacement and gene editing, used for genetic disorders and some cancers. Xenografts are animal-tissue-derived products, such as heart valves, used in cardiology and orthopedics.
These three categories now join vaccines, large-volume IV parenterals, and r-DNA-based medicines under CLAA. All these categories get joint Central-State regulatory oversight, not state-only approval.
1 July 2026: Separately, the Ministry of Health and Family Welfare released a revised Draft National Pharmacy Commission (NPC) Bill, 2026, for public comment. This is a different body from IPC. If passed, it would repeal the Pharmacy Act, 1948, and create a National Pharmacy Commission instead. That would mirror how the National Medical Commission already replaced the Medical Council of India for doctors. This bill is still a draft, not a passed law. Stakeholder comments were due by 31 July 2026. (Source: PIB)
On 24 June 2026, IPC held a National Conference on blood and blood component quality, at its Ghaziabad campus. It marked the rollout of IP 2026’s new blood standards — the first pharmacopoeia in the world to carry them. (Source: PIB)
More than 160 professionals attended, from six states: Uttar Pradesh, Rajasthan, Uttarakhand, Haryana, Punjab, and Madhya Pradesh. (Source: PIB)
From 22 to 23 June 2026, IPC also ran its second hands-on training, on detecting Ethylene Glycol (EG) and Diethylene Glycol (DEG) in oral liquid medicines. Both are toxic contaminants, sometimes introduced through substandard excipients. (Source: PIB)
This training followed Amendment List 09 to IP-2022, effective from October 2025. It made EG/DEG testing mandatory, for all oral liquid formulations. (Source: PIB)