[Answered] Adverse reports on Indian medicines, such as those from the Gambia, could dent the country’s well-earned reputation of being the pharmacy of the Third World. In light of the statement, discuss the steps required to maintain India’s trust in the field of Pharmaceuticals.

India is considered as the ‘pharmacy of the world’ due to its ability to produce a wide range and great volume of medicines, that too at low costs. The Drug and Cosmetics Act, 1940 establishes regulatory control over the import, manufacture, distribution, and sale of drugs and cosmetics in India.

Recently Cough syrups manufactured by Maiden Pharmaceuticals have caused the deaths of 66 children in Gambia. To avoid such incidents in future and to maintain India’s trust in the field of Pharmaceuticals, following steps are required:

• The Central Drugs Standard Control Organization (CDSCO) must be empowered to conduct surprise inspections of manufacturing plants. The plants can be graded accordingly to help consumers understand the differences in the quality of the drugs.
• A rigorous regulatory regime is needed to ensure India remains the pharmacy of the world and provides affordable medicines to the poorest sections of society also.
• There is need to regulate the sale of substandard, even counterfeit, drugswhich remain widespread in India, particularly, in smaller towns and villages.
• Raw materials produced from small scale units should be properly validated in the testing laboratory of the state to ascertain their quality specifications.
• There is a need for a functional testing laboratory in every state to fasten the work of specification of raw materials.
• Skilled manpower from academic institutions can be achieved through continuing education programmes.
• Research schemes should be initiated by the industry via direct contact with identified researcher/faculty.
• Focus on API manufacturing so that they can less rely on imported APIs. This can be fulfilled in several ways, including constructing dedicated zones for the manufacture of APIs.
• AI can be used for drug discovery, development, manufacturing, and marketing. AI can make all business operations efficient, cost-effective, and hassle-free.

The sale of substandard drugs in India has to be stopped not only because it is illegal but because it is creating life-threatening situations. A mechanism should be built, where regulators should have proper communication links between them. Also, a set of uniform standards should be followed.