The Pharmacovigilance Programme of India (PvPI) is an Indian government organization which identifies and responds to drug safety problems. Its activities include receiving reports of

adverse drug events An adverse drug reaction (ADR) is a harmful, unintended result caused by taking medication. ADRs may occur following a single dose or prolonged administration of a drug or result from the combination of two or more drugs. The meaning of this term ...

and taking necessary action to remedy problems. The

Central Drugs Standard Control Organisation The Central Drugs Standard Control Organisation (CDSCO) is India's national regulatory body for cosmetics , pharmaceuticals and medical devices. It serves a similar function to the European Medicines Agency of the European Union, the PMDA of ...

established the program in July 2010 with

All India Institute of Medical Sciences, New Delhi All India Institute of Medical Sciences, New Delhi, also known as AIIMS Delhi, is a public medical research university and hospital in New Delhi, India. The institute is governed by the AIIMS Act, 1956 and operates autonomously under the Mini ...

as the National Coordination Centre, which later shifted to

Indian Pharmacopoeia Commission Indian Pharmacopoeia Commission (IPC) is an autonomous institution of the Ministry of Health and Family Welfare which sets standards for all drugs that are manufactured, sold and consumed in India. The set of standards are published under th ...

in Ghaziabad on 15 April 2011.

History

Many developed countries set up their pharmacovigilance programs following the Thalidomide scandal in the 1960s. India set up its program in the 1980s. This general concept of drug safety monitoring went through different forms, but the

established the present Pharmacovigilance Program of India in 2010. Now the program is well integrated with government legislation, a regulator as leader, and a research center as part of the

Activities

As of 2018 there were 250 centers around India capable of responding to reports of serious adverse reactions. One of the challenges of the organization is training doctors and hospitals to report adverse drug reactions when patients have them. The Pharmacovigilance Program makes these reports itself, but ideally, such reports could originate from any clinic. The Pharmacovigilance Programme seeks to encourage a culture and social expectation of reporting drug problems. One of the successes of the program was detecting adverse effects of people in India using carbamazepine. While this drug is safer among people native to the Europe, people of South Asia have different genetics and are more likely to experience problems when using it. Other countries could not have been able to detect this problem, and the Pharmacovigilance Programme's detection of it was a success story.

Collaboration

The establishment of the Pharmacovigilance Program made India a more attractive international destination for foreign companies to bring clinical trials research. Understanding the quality of India's pharmacovigilance programme is key to international researchers conducting trials in India. The program collaborates both in India and internationally with the World Health Organization on projects for safe medication. As a collaborating center, the Pharmacovigilance Programme assists the WHO in developing international policy for other countries to manage their own drug safety programs. While the United States and Europe have pharmacovigilance systems which are developed well in some ways, the Indian programme has more and specialized expertise to apply for the unique circumstances of India. The

Pharmaceutical industry in India The pharmaceutical industry in India was valued at an estimated US$42 billion in 2021. India is the world's largest provider of generic medicines by volume, with a 20% share of total global pharmaceutical exports. It is also the largest vaccine ...

produces more drugs than any other national industry. Because of the large amount of drugs and the many countries which import them, the Indian program monitors in some ways more than anywhere else.

References

External links

* {{Clinical trials in India, state=expanded Drug safety Pharmaceuticals policy Medical and health organisations based in India National agencies for drug regulation Regulators of biotechnology products Regulatory agencies of India Ministry of Health and Family Welfare