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Legal framework of PV for medicines marketed in India


Rajdutt Shekhar Singh, Partner, Singh & Associates, gives an insight on the status and objective of pharmacovigilance programme in India

As per the World Health Organization (WHO), Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem. Together with the WHO Collaborating Centre for International Drug Monitoring, Uppsala (WHO-Uppsala Monitoring Centre – WHO-UMC), WHO promotes PV at the country level. Currently, 131 countries are members of the WHO Programme for International Drug Monitoring. [1] The objective of PV is to enhance patient care and patient safety in relation to the use of medicines; and to support public health programmes by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines.[2]

Pharmacovigilance programme of India

India is a member of WHO Programme for International Drug Monitoring. The Central Drugs Standard Control Organisation (CDSCO), New Delhi, under the aegis of Ministry of Health & Family Welfare, initiated a nation-wide Pharmacovigilance Program of India (PvPI) in July 2010. The programme was launched with a broad objective to safeguard the health of 1.27 billion people of India. The Indian Pharmacopoeia Commission (IPC) acts as the National Coordinating Centre (NCC)-PvPI, where Adverse Drug Reactions (ADRs) are reported from all over the country. IPC also works in collaboration with the global ADR monitoring center (WHO-Uppsala Monitoring Centre (UMC)), Sweden to contribute to the global ADRs database.

Spontaneous reports of ADRs due to use of medicines, vaccines, medical devices and herbal products from healthcare professionals and consumers/patients are evaluated and corrected under PvPI. ADR Monitoring Centres (AMCs) have been set up all over India in order to monitor ADRs and reporting the same to NCC-PvPI. At present, 250 AMCs (medical colleges, district, and corporate hospitals, etc.) are enrolled under PvPI across the country. In addition, IPC issues monthly drug safety alerts, which includes risk-prone drugs, based on the preliminary analysis of Suspected Unexpected Serious Adverse Reactions (SUSARs) from the PvPI database. It also advises professionals and patients/ consumers to closely monitor and report the possibility of adverse events of notified drugs when such medicines are prescribed or consumed.[3]

Legal framework

The Drugs and Cosmetics Act, 1940 (D&C Act) mandates pharmacovigilance and post-marketing surveillance. In cases of import, manufacturing of new drug, grant of the registration certificate, etc., the D&C Act states as follows:

  • Permission to import finished formulation of a new drug (Form 45); Condition (5) [4] of Form 45 requires a Periodic Safety Update Report (PSUR) submission as one of the conditions for grant of permission to import the finished formulation of a new drug.
  • Permission/ Approval for the manufacture of new drug formulation (Form 46); Condition (5) of Form 46 also requires a PSUR submission. [5]
  • Condition to report under the Registration Certificate (Form 41); whereas Condition (4) of Form 41 requires the manufacturer or his authorised agent in India to inform the licensing authority, in the event of any administrative action taken due to an adverse reaction.[6]
  • Good Manufacturing Practice (Schedule M): Paragraph 28 of Part 1 of Schedule M states that the serious adverse reaction should be reported to licensing authority by the licensee in the following manner:

Paragraph 28 of Part 1 of Schedule M: Complaints and Adverse Reactions:

I. All complaints thereof concerning product quality shall be carefully reviewed and recorded according to written procedures. Each complaint shall be investigated/evaluated by the designated personnel of the company and records of investigation and remedial action taken thereof shall be maintained.
II. Reports of serious adverse drug reactions resulting from the use of a drug along with comments and documents shall be forthwith reported to the concerned licensing authority.
III. There shall be written procedures describing the action to be taken, recall to be made of the defective product.

  • Requirements and Guidelines for Permission to Import And/ Or Manufacture of New Drugs for Sale or To Undertake Clinical Trial (Schedule Y); Condition (4) of Paragraph 3 (Studies in special populations) of Schedule Y requires the applicant to have a pharmacovigilance system in place.

Pharmacovigilance guidance document for Marketing Authorization Holders (MAHs)

In the pharmaceutical domain, a MAH is referred to a pharma company or sponsor of the product, who holds the license to market a particular product in the territory. In order to ensure smooth functioning of pharmacovigilance activities by pharma industries, in October 2017, the Secretary of the Ministry of Health and Family Welfare, Government of India, released the Pharmacovigilance Guidance Document (Guidance Document), effective from January 2018 for MAHs of pharma products. [7]

The aforesaid guidance document (GD) had been developed by IPC (NCC-PvPI) in collaboration with CDSCO to provide assistance to MAHs for establishing and ensuring an effective PV system at their site. The GD comprises six modules viz. PV System master file, collection, processing and reporting of individual case safety reports, preparation and submission of periodic safety update report, quality management system at marketing authorisation holder organisation, audits and inspections of pharmacovigilance system at MAH organisation and submission of risk management plan. The GD directs MAHs to establish a PV system with a medical officer or a pharmacist who shall act as a PV officer-in-charge for collection and analysis of ADR reports related to pharma products marketed by them in India.


The PV programme in India is regulated and operated by CDSCO, IPC, Drug Regulatory Authorities and the MAHs. NCC-PvPI monitor the ADRs sighted in the Indian population and helps the regulatory authorities in taking a decision for safe use of medicines. With the inclusion of the aforesaid GD, the identification, reporting, and mitigation of risks related to pharma products would be streamlined in a systematic manner.

[1] global-pharmacovigilance/ members/
[3] showfile. asp?lid=833&EncHid=
[4] Condition (5) of Form 45-Post-marketing surveillance study shall be conducted during an initial period of two years of marketing of the new drug formulation, after getting the protocol and the names of the investigator duly approved by the Licensing Authority.
[5] Condition (5) of Form 46- Post-marketing surveillance study shall be conducted during an initial period of two years of marketing of the new drug formulation, after getting the protocol and the names of the investigator duly approved by the Licensing Authority.
[6]Condition (4) of Form 41-[The manufacturer or his authorised agent in India shall inform the licensing authority forthwith in the event of any administrative action taken due to adverse reaction, viz. market withdrawal, regulatory restrictions, or cancellation of authorization, and/or not of standard quality report of any drug pertaining to this Registration Certificate declared by the Regulatory Authority of the country of origin or by any Regulatory Authority of any other country, where the drug is marketed/ sold or distributed…….]

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