Regulatory Standards in Pharmaceuticals and Consumers: Missing Links

Abstract

In a study on the regulatory standards in pharmaceuticals in India, this chapter points out that these regulations are industry-centric and do not aim to inform the consumers. While the economic reforms helped opening up the market for Indian drugs elsewhere, it also brought in improved standards of quality to be followed in the entire supply chain of drugs. Strict implementation of the same has resulted in the closure of units in different states and even the public sector vaccine units in the recent years. The regulatory standards though increased the documentation and related expenditure, also widened the export opportunities for the manufacturers. For the consumers, these regulations resulted in improved drugs, as the public health system also started emphasizing on getting supplies only from those manufacturers with quality standards. Environmental violations are observed in certain manufacturing pockets, which could lead to potential health hazards for people in those areas. Pharmacovigilance practices in the country need to improve so that adverse drug reactions among consumers are documented appropriately. Due to lack of these data, drugs that were proved to be unsafe for consumption and withdrawn from several countries are not withdrawn from the domestic market and more importantly such withdrawal orders are stayed by the legal courts.