Utmost patient safety in prescribing and administering drugs is considered to be the cornerstone of the medical practice. Drugs and pharmaceuticals are produced by pharmaceutical industry and approval for marketing the same is granted by the national regulatory authorities after duly verifying their efficacy and safety profile. But even after three phase clinical trials, all approved medicines are not always found to be totally safe as trials are usually limited to a few thousands of patients. Withdrawal of several approved drugs in recent years from the US, European and Indian markets for severe adverse reactions establishes this fact. It is possible that either all adverse reactions of drugs cannot be assessed correctly from a limited group of subjects during trials or the process of trials in some cases could be faulty with marketing approvals are granted by oversight. These possibilities underline the need for submission of post marketing surveillance of all approved drugs with the regulatory authorities by the pharmaceutical companies for some years after the launch.
In India, Schedule Y of the Drugs & Cosmetics Act was amended in 2005 with the intention of making obligatory for submission of post marketing drug safety for Marketing Authorization Holders. This regulation was strengthened by a CDSCO order later in August 2012 and structured it as per clause 4, sub clause (v) of Schedule Y of the D&C Rules mandating submission of Periodic Safety Update Reports (PSUR) of all new drugs to DCGI every six months for the first two years of launch and annually for the next two years. Although submission of post marketing surveillance data is mandatory on the pharmaceutical companies, most of the companies do not care to submit such reports to the DCGI. The Parliamentary standing committee on health & family welfare in 2013 had taken serious note of this deficiency in enforcement of this rule by the office of the DCGI. The Committee had then asked the health ministry to direct CDSCO to send out a warning to all companies marketing new drugs to comply with PSUR submission or face suspension of marketing approval. To what extend CDSCO or DCGI enforced this directive of the Committee on pharma companies is not known. Now to strengthen the pharmacovigilance by the pharma companies the Pharmacy Council of India and Indian Council of Medical Research have suggested setting up of a pharmacovigilance system within the company. In most of the companies such a system does not exist. These needs to be done by amending Schedule Y of the D&C Act further to make post marketing surveillance mandatory for the applicant companies.