Drugs and Cosmetics Act, 1940-The Hindu-13-10-2022
PRELIM AND MAINS:
Drugs and Cosmetics Act, 1940:
The Act regulates the import, manufacture, and distribution of drugs in India.
The primary objective of the act is to ensure that the drugs and cosmetics sold in India are safe, effective and conform to state quality standards.
Section 3 of the Drugs and Cosmetics Act, 1940:
The Central Government, after consultation with the Drugs Technical Advisory Board (DTAB), specifies the devices intended for use in human beings or animals as drugs.
At present, only 23 medical devices have been classified as drugs. The latest notification gives a wide definition of the term medical devices.
The devices used for diagnosis, monitoring, treatment, assistance for any injury or disability, investigation, replacement or modification or support of the anatomy or of a physiological process will come within the scope of the definition of ‘Drugs’.
Medical equipment under this definition include implantable medical devices such as knee implants, CT scan, MRI equipment, defibrillators, dialysis machine, PET equipment, X-ray machine etc.
Primary intended action of the device in or on human body or animals should not be pharmacological or immunological or metabolic.
The aim is to regulate all medical devices so that they meet certain standards of quality. Besides it will also make medical device companies accountable for quality and safety of their products.
The manufacture, import and sale of all medical devices will now need to be certified by the Central Drugs Standard Control Organisation.
Only in rules: Currently all these provisions are there in the Rules but now it has been proposed in the bill.
No penalty provision: in the existing rules there is no provision to impose penalties such imprisonment on the erring firms or persons for failure to provide compensation to trial participants in the clinical trial for both drugs and medical devices.
No separate definition: In the existing Act, medical devices are treated as drugs and there is no separate definition of medical devices.
Many do not have a licence and just sell drugs that are available with other licensed stockists.
International practices: Separate chapters for medical devices will give distinct treatment to it in line with international practices to boost quality, consumer confidence and expectations of the stakeholders.
Provisions have been made for risk-based classification of medical devices based on their intended use, risk and vulnerability to the human body.