Pharmacovigilance obligations of the pharmaceutical companies in India

The decision to approve a new drug is based on its having a satisfactory balance of benefits and risks on the basis of the information available at that time. Once a product is marketed, new information will be generated, which may have an impact on the benefit-risk profile of the product. The detailed evaluation of the new information generated through pharmacovigilance activities is important for all products to ensure their safe use. No degree of care and caution at the pre-clinical and clinical testing stages can guarantee an absolute safety when a product is marketed and prescribed in large populations with settings different from the clinical trials. Thus, a strong pharmacovigilance system is required to ensure the continuous monitoring and evaluation of the new safety data generated under the real-world conditions on the effects, side effects, contraindications, drug interactions, new indications and use in new populations of all drugs. Indian market has mostly seen the launch of only those products that have been already approved and marketed in the regulated markets of USA, Europe, Japan or other countries. For assessing the benefit-risk profile of a drug and to take appropriate corrective actions, the Indian pharmaceutical companies as well as the regulators have been depending on the experiences gained from these markets where the drug was being used for several years before introduction in India, thus bypassing the requirement to establish a strong pharmacovigilance system of their own. In recent years, many Indian companies are increasing the investment in research and development and are enhancing their capacity to develop and market new drugs with their own research efforts. Further, India is becoming a hub for clinical research activities due to its large population, high enrolment rate, and low cost. Moreover, the lag period when a drug is placed for the first time on the market in USA, Europe, Japan or somewhere else in the world, and its subsequent availability in India has decreased considerably. As a result, for such drugs the long-term safety data is not available and the time of their marketing in India.[1,2] This is clear by the fact that all the high-profile drugs that have been recently withdrawn were available in Indian market. In such cases, the Indian regulatory agencies cannot count on the experience of other markets to assess benefit-risk balance of a drug, thereby stressing the importance of developing their own adequately designed pharmacovigilance system in India. All these factors have drawn the attention of not only Drugs Controller General of India (DCGI), but also of World Health Organization (WHO), and the pharmaceutical companies toward the inadequacy of pharmacovigilance systems in India. For an effective pharmacovigilance system to be functional and efficient, all the stakeholders need to be alert and attentive through out the lifecycle of a medicinal product in the market. The office of the DCGI has been making sincere attempts for the implementation the National Pharmacovigilance Program (NPP)[3] in India. Further, the Schedule Y[4] of the Drugs and Cosmetics Act 1945 was thoroughly reviewed and amended in 2005 to include and elaborate the pharmacovigilance obligations of the companies attempting to market/develop new drugs in India. This article provides the details of the pharmacovigilance obligations of the pharmaceutical companies marketing their products in India, for generic products, for clinical trials of new chemical entity (NCE) and Indian pharmaceutical companies with pharmacovigilance headquarters in India and subsidiaries in other countries.