New Delhi: The government has set a target of opening 10,000 Pradhan Mantri Bhartiya Janaushadhi Kendras (PMBJKs) by March to enhance the accessibility of affordable generic medicines for the general public, as revealed by Union Health Minister Mansukh Mandaviya during a Lok Sabha session on Friday. Up until June 30, a total of 9,512 PMBJKs have already been established throughout the country.
As per the Indian Medical Council (Professional Conduct, Etiquette, and Ethics) Regulations of 2002, it is mandated that all physicians should prescribe drugs using generic names in a clear and preferably capitalized manner. This directive was stated in a written response by the Health Minister to a question asked in the House.
Moreover, the Directorate General of Health Services has issued instructions to all government hospitals to exclusively prescribe generic medicines. Similar directives have also been extended to doctors and wellness centers under the Central Government Health Scheme (CGHS).
Additionally, the National Health Mission (NHM) supports the provision of essential generic drugs free of cost in public health facilities under the free drug initiative.
To promote the PMBJP scheme, the Department of Pharmaceuticals and the Pharmaceuticals and Medical Devices Bureau of India (PMBI), the implementing agency of the scheme, periodically requests state and union territory governments as well as district administrations to raise awareness about the scheme and provide rent-free space for establishing Janaushadhi Kendras in Community Health Centers, Primary Health Centers, and government hospitals.
In the interest of ensuring the quality of medicines in the country, the Central Drugs Standard Control Organization (CDSCO) and Ministry of Health have implemented several regulatory measures. Notably, the Drugs and Cosmetics Act of 1940 was amended under the Drugs and Cosmetics (Amendment) Act of 2008 to impose strict penalties for the manufacturing of counterfeit and adulterated drugs. Certain offenses have been made cognizable and non-bailable. Additionally, special courts have been established by states and union territories for the expedited trial of offenses under the Drugs and Cosmetics Act.
Over the past decade, the number of sanctioned positions within the Central Drugs Standard Control Organization (CDSCO) has seen a significant increase, according to Mandaiya.
Furthermore, to ensure the effectiveness of drugs, the Drugs and Cosmetics Rules of 1945 have been amended to require applicants to submit the results of bioequivalence studies along with their applications for manufacturing licenses of oral dosage forms for certain drugs.
Another amendment to the Drugs and Cosmetics Rules of 1945 mandates a joint inspection of the manufacturing establishment by Drugs Inspectors from both the central government and state government before granting a manufacturing license. In addition, the rules now require applicants to submit evidence regarding stability and the safety of excipients to the State Licensing Authority prior to the grant of a manufacturing license by the Authority, as highlighted by the minister.
