Context: With the expansion of Janaushadhi Kendra to more than 10,000 centers the pharma companies are facing losses. 

Generic Medicines and Their Impact on the Pharmaceutical Industry:

The increasing prevalence of generic medicines is negatively affecting the growth of the domestic pharmaceutical market valued at Rs 1.9 lakh crore.

Janaushadhi Kendra: Janaushadhi Kendras are outlets that offer generic drugs priced 50 to 60 percent lower than well-known brands. The initiative is spearheaded by the Pharma & Medical Bureau of India (PMBI), under the Ministry of Chemicals and Fertilizers.

Social Benefits: A noteworthy aspect is that many Janaushadhi stores are managed by women entrepreneurs, particularly in regions like Kerala.

Distribution Insights: Presently, 33 percent of these stores are situated in South India. Uttar Pradesh leads with the highest number of Janaushadhi stores, totaling 1,481.

Drug Statistics: Five among the top 10 selling drugs at Janaushadhi kendras nationwide are associated with the treatment of diabetes and hypertension.

About Generic Drugs: Generic drugs have a comparable composition to branded drugs but are produced after the patent expiration. India predominantly operates as a market for branded generic drugs, where various pharmaceutical companies market their own brands of generic molecules.

Low-Cost Advantage:

Trade generics are directly supplied to hospitals and dispensaries, leading to significantly lower prices for non-branded generics due to the absence of marketing costs.

Definition and Distinctions between Generic Medicines and Branded Drugs:

A generic drug is a pharmaceutical product that comprises identical active ingredient(s), dosage form, strength, and therapeutic effect as a reference product but is marketed under a different name.

Comparison of Generic Medicines and Branded Drugs:

Advantages of Using Generic Medicines:

Cost-effectiveness: Generic Medicines are generally more economical than brand-name drugs, enhancing healthcare affordability and reducing financial burdens on patients and healthcare systems.

Increased Access: The availability of Generic Medicines expands access to essential medications, particularly benefiting economically disadvantaged populations.

Equivalent Quality and Efficacy: Generic Medicines adhere to stringent regulatory standards, ensuring bioequivalence to brand-name drugs, thus offering comparable quality and efficacy.

Competition and Innovation: Enhanced competition among generic drug manufacturers can stimulate innovation and lead to reduced prices, benefiting consumers.

Regulatory Mechanisms for Generic Medicines in the Indian Pharmaceutical Industry:

The regulatory framework for Generic Medicines in India is governed by the Drugs and Cosmetics Act, 1940, and Rules, 1945.

Central Drugs Standard Control Organization (CDSCO): CDSCO serves as the national regulatory authority, responsible for reviewing and approving generic drug applications, conducting facility inspections, and ensuring compliance.

National Pharmaceutical Pricing Authority (NPPA): NPPA oversees the regulation of drug prices in India, contributing to the control and maintenance of fair pricing within the pharmaceutical sector.