The Drugs and Cosmetics Act 1940 is an old law enforced in the pre-independence era. Since 2016, the Government have made various amendments to this law. In this view, on 8 July 2022, the Central Government of India proposed a draft New Drugs, Medical Devices and Cosmetics Bill, 2022 to keep pace with changing times, needs and technology.
The Act may be called The Drugs, Medical Devices and Cosmetics Bill, 2022. It will be applied to the entire Indian territory. This bill is proposed to amend the law relating to the manufacture, import, distribution and sale of drugs, medical devices and cosmetics to ensure their quality, efficacy, safety, performance and clinical trial of new drugs and clinical investigation of investigational medical devices. It will come into force on such date as the Central Government decides. This notification encloses the following draft bill.
The provisions of this Act are not in derogation/exemption of any other law. This Act states the following-
This bill defines different boards- the Drugs Technical Advisory Board constituted under section 5; the Medical Devices Technical Advisory Board constituted under section 6; Central Drugs Laboratory designated under section 10; Central License Approving Authority; Central Licensing Authority; Central medical devices testing centre, etc.
Any substance specified as poisonous by rules made under Chapter III, IV or Chapter V will be considered poisonous.
Chapter II- defines the members of the Drugs Technical Advisory Board. It will comprise a Chairperson, Secretary and each person from medical/ biotechnology background, appointed by the Central Government of India. The Tenure of nominated members will be for three years from the date of their appointment.
Chapter III- defines the standards of quality of imported drugs or cosmetics. The imported drugs and cosmetics should comply with standards (quality, labelling) set out in the First Schedule and as may be prescribed.
Chapter IV- defines the standards of quality of drugs and cosmetics for manufacture, sale and distribution of drugs and cosmetics and clinical trial of drugs.
Chapter V- defines the provisions relating to Ayurveda, Siddha, Sowa Rigpa, Unani and Homoeopathic drugs. It states that “Ayurveda, Siddha, Sowa Rigpa, Unani and drugs” includes all medicines intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals.
Chapter VI- defines the standards and regulations for the import, manufacture, sale, distribution and conduct of the clinical investigation of medical devices.
Chapter VII- defines that the Central Government may give the power to any State Government to execute in the State any of the provisions of this Act or any rule or order made thereunder. The Central Government may appoint the Drugs Controller General, India and Central License Approving Authority.
First Schedule- defines the standards that must comply with imported drugs and drugs manufactured for sale, sold, stocked or exhibited for sale or distributed.
The Second Schedule states the payable fee for license, permission, registration certificate and approval.
The Third Schedule states the categories of drugs for which CLA approval is required for the licence issue.
The Fourth Schedule includes the categories of misbranded drugs and Fifth Schedule states the AYURVEDIC, SIDDHA AND SOWA RIGPA systems, etc.