Pharma companies will soon need to set up a Pharmacovigilance system for the post marketing surveillance of their new drugs manufactured or imported for sales in the market as the ministry of health and family welfare (MoHFW) has come up with the draft amendment of the Schedule Y of Drugs and Cosmetics Act, 1940.
The central government in consultation with Drug Testing Advisory Board (DTAB) is coming up with a draft for the pharma industry to put in place a system for collecting, processing and forwarding the report to the licensing authority for information on Adverse Drug Reactions (ADR) emerging from the use of the drug manufactured or marketed by the companies in the country.
Dr. B Suresh, president of PCI and member of DTAB says, “As per Phramacovigilance Programme of India (PvPI) the ADR of the drugs are presently being reported by only by the hospitals and very few companies are involved in reporting of ADR. So the government has decided to make it mandatory for the industry to have pharmcovigilance system, so that PVPI will also have ADR data from the industry as well.”
He further says, “It is mandatory for all pharma companies big or small to have a pharmacovigilance system. This initiative will have two outcomes. Firstly it will assure patients safety and second it will also generate employment opportunities as it is mandatory to recruit pharma graduate to work in their pharmacovigilance system.”
The system shall be managed by qualified and trained personnel and the officer in-charge of collection and processing of data shall be a medical officer or a pharmacist trained in collection and analysis of adverse drug reaction reports.
Subsequent to approval of the product, new drug shall be closely monitored for its clinical safety once it is marketed. The companies shall furnish Periodic Safety Update Reports (PSURs) in order to report all relevant new information from appropriate sources; relate the data to patient exposure; summarise the market authorisation status in different countries and any significant variations related to safety; and indicate whether changes shall be made to product information in order to optimise the use of product.
The said rule will be included in schedule Y of Drugs and Cosmetics Act, 1940 after it comes into force on the date of their publication in the official gazette.
The mission of PvPI is to safeguard the health of the Indian population by ensuring that the benefit of use of medicine outweighs the risks associated with its use. ADRs are reported from all over the country to NCC-PvPI, which also work in collaboration with the global ADR monitoring centre (WHO-UMC), Sweden to contribute in the global ADRs data base. NCC-PvPI monitors the ADRs among Indian population and helps the regulatory authority of India in taking decision for safe use of medicines. The PvPI was launched in India with the vision to improve patient safety and welfare monitoring drug safety and thereby reducing the risk associated with use of medicines.