By: Mohammad Shahbaz Alam

New Delhi

Medicine is a double edged sword either saves life or kills life. Safety of medicine is a serious concern and it depends how you care medicine on all distribution points from manufacturing to distribution, distributor to retailer, retailer to patient and storage condition in different points. Second most import thing how clinicians respond to the company regarding adverse effects of medicine and how vigilant a company in collecting and responding to the regulatory body and to the society.

Pharmacovigilance is a continuous process of collection, monitoring, evaluation and reporting of suspects’adverse drug reactions coming out from clinical trials and post marketing surveillance,including expedited reporting of serious unexpectedadverse reactions and preparation of the PSURs. In pharmacovigilanceonly drug induced ADR has to study.

Once aproduct is marketed, new information will be generated, which may have an impacton the benefit-risk profile of the product. The detailed evaluation of the newinformation generated through pharmacovigilance activities is important for allproducts to ensure their safe use. No degree of care and caution at thepre-clinical and clinical testing stages can guarantee an absolute safety whena product is marketed and prescribed in large populations with settingsdifferent from the clinical trials. Thus, a strong pharmacovigilance system isrequired to ensure the continuous monitoring and evaluation of the new safetydata generated under the real-world conditions on the effects, side effects,contraindications, drug interactions, new indications and use in newpopulations of all drugs.

For an effectivepharmacovigilance system to be functional and efficient, all the stakeholders DCGI,WHO,and the pharmaceutical companies need to be alert and attentive throughout thelifecycle of a medicinal product in the market.

National PharmacovigilanceProgram (NPP)  is a nation-wide program, sponsored andcoordinated by the country′s Central Drugs Standards Control Organization(CDSCO) to established and manage a database of adverse drug reactions (ADRs)for making informed regulatory decisions regarding marketing authorization ofdrugs in India for ensuring safety of drugs

In India, a pharmaceuticalcompany holding the marketing license should ensure that they have adequatepharmacovigilance system in place to ensure the responsibility and liability oftheir marketed products, as specified in Schedule Y. A pharmaceutical companycan achieve this either by setting up in-house systems for pharmacovigilance orcan enter into contractual arrangements with CROs or any organisationspecializing in pharmacovigilance function for meeting their pharmacovigilanceobligations.

Format of PSUR provided in theSchedule Y is not similar to that of ICH E2C[8] format, although it does not elaborately guide the contents of thedata to be incorporated under each and every heading. For all practicalpurposes, a PSUR prepared in accordance with ICH E2C format should beacceptable to DCGI. Apart from PSUR all marketingauthorisation holders to have one qualified person for pharmacovigilance (QPPV)with responsibility for establishing and maintaining all aspects of thecompany’s global pharmacovigilance system.

Thanks to “RabDi Meher” NGO for providing all valuable information and you may contact forfurther information at

Implementationpart of pharmacovigilance in India is still on paper and it has been proved inDelhi High Court when both government and companies were unable to produce ADRreport.Strict implementation is required to provide safe medicine for all andto make India a safe Heaven for safe drug.Jai Ho,

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