The Ministry of Health and Family Welfare has issued an Update on Access to Generic Medicines provided under the Pradhan Mantri Bhartiya Janaushadhi Kendras opened across the country. In order to promote the PMBJP scheme, the Department of Pharmaceuticals and Pharmaceuticals & Medical Devices Bureau of India (PMBI), the implementing agency of scheme periodically requests state/UT governments/ district administrations to create awareness about the scheme and provide rent free space for opening Janaushadhi Kendras in Community Health Centre (CHC)/ Primary Health Centre (PHC)/Government Hospitals.
CDSCO and Ministry of Health and Family Welfare have taken following regulatory measures to ensure the quality of medicines in the country:-
(i). The Drugs and Cosmetics Act, 1940 was amended under Drugs & Cosmetics (Amendment) Act 2008 to provide stringent penalties for manufacture of spurious and adulterated drugs. Certain offences have also been made cognizable and non-bailable.
(ii). States / UTs have set up special Courts for trial of offences under the Drugs and Cosmetics Act for speedy disposal.
(iii). The number of sanctioned posts in Central Drugs Standard Control Organization (CDSCO) has been significantly increased in last 10 years.
(iv). To ensure efficacy of drugs, the Drugs and Cosmetics Rules, 1945 have been amended providing that applicant shall submit the result of bioequivalence study along with the application for grant of manufacturing license of oral dosage form of some drugs.
(v). The Drugs and Cosmetics Rules, 1945 have been amended making it mandatory that before the grant of manufacturing license, the manufacturing establishment is to be inspected jointly by the Drugs Inspectors of Central Government and State Government.
(vi). The Drugs and Cosmetics Rules, 1945 have been amended, making it mandatory that the applicants shall submit evidence of stability, safety of excipients etc. to the State Licensing Authority before grant of manufacturing license by the Authority.
