The old Drugs and Cosmetics Act, 1940 is to be replaced by the New Drugs, Medical Devices and Cosmetics Bill, 2022. Ministry of Health and Family Welfare, Government of India proposes a draft New Drugs, Medical Devices and Cosmetics Bill, 2022 in order to keep pace with changing needs, times, technology.
The Drugs and Cosmetics Act, 1940 is a pre-independence legislation enacted by the Central Legislative Assembly. Review of obsolete laws and updating of the existing laws is a continuing process to accommodate changed requirements and adaptation of new technology.
The Government has time and again emphasized the need to review obsolete laws and to periodically repeal and amend laws, for which Bill are being brought before the Parliament. The work of review and updating of Drugs and Cosmetics Rules, 1945 was vigorously taken up from the year 2016.
In light of recommendations of the Central Government and the felt need to have comprehensive legislation,a committee was constituted for framing the New Drugs, Cosmetics and Medical Devices Bill.
In this new bill, Government is trying to cover untouch areas of pharmaceutical and medical devices field. Also, new bill doesnot specifies role of pharmacist in dispensing of medicines.
There will be Medical Devices Technical Advisory Board along with Drug Technical Advisory Board. And The Central Government may remove any member nominated from office in above mentioned boards.
Central Government shall constitute a consultative committee to be called the Drugs, Medical Devices and Cosmetics Consultative Committee to advise the Central Government, the State Governments, the Drugs Technical Advisory Board and the Medical Devices Technical Advisory Board on any matter tending to secure uniformity in the country in the administration of this Act and the rules.
Central Government will also establish one or more special courts in consulation with states high court for trial of offences relating to adulterated drugs or spurious drugs and punishable under clauses.
Health ministry also specifies Fee payable for license, permission, registration certificate and approval of medicines in the country.
Drugs, Medical Devices and Cosmetics Bill, 2022 specifies parameters that should be pass for any standard quality drugs. It includes absorbency; acid value, iodine value, peroxide value, saponification value, acetyl value; ash value; assay (more than seventy per cent. and less than the prescribed limit of label claim); boiling point; clarity of solution; description; disintegration; dissolution (twenty per cent. less than minimum limit of specification); extractable volume; extractive value; fluorescence; heavy metal; leak test (meter dose preparation); limit test; loss on drying; loss on ignition; melting point; number of deliveries per container (meter dose preparation); optical rotation; osmolality; particle size; particulate contamination/ foreign matter; pouvoir hydrogen (pH) test; polymorph; refractive index; related substance ; solubility test; specific gravity; sulphated ash; thread count; total organic carbon; uniformity of content/volume; uniformity of delivered dose (meter dose preparation); uniformity of dispersion; uniformity of weight; viscosity; water content/moisture content; weight per mL; wt/unit area (surgical); acidity; appearance of solution; chiral purity.
