Even as the Union government is engaged in the process of finalising changes to the Drugs and Cosmetics (Amendment) Bill 2015, a retired regulator and member of the Pharmacy Council of India (PCI) from Kerala has made a proposal to the director of drugs, Department of health and family welfare that there need not be separate Technical Advisory Boards for drugs and medical devices because the medical devices are also coming under the category of drugs.

After carrying out a detailed study of the draft bill of the D&C Act (amendment) Bill, he suggested that only one common Technical Advisory Board for both drugs and medical devices is sufficient and it should be termed as Drugs and Medical Devices Technical Advisory Board (DMDTAB). The new Board should be constituted by combining the present DTAB and MDTAB.

M K Unnikrishna Panicker, the PCI member argues that the constitution of a common Board will reduce the administrative expenditures incurring for technical advice, and it must be included experts from both the fields. He has forwarded the proposals to Dr Shailendra Kumar, director (drugs), Department of health and family welfare, New Delhi, after holding excessive discussion with regulatory staffs and pharmacy council members in Thiruvananthapuram.

Another significant change suggested for consideration is that a provision must be made in the draft bill to appoint a separate analyst to check the quality of medical devices. Panicker justifies that the D&C Act primarily aims at making available quality drugs or medical devices, hence ensuring the quality of medical devices is important. He says that going by the definition of drugs 7(j) and medical devices 7(v) in the principal act, it is seen that in both the definitions it is stated as ‘for use in human beings or animals for diagnosis or mitigation or treatment’, hence a separate definition is not required in the same Act. The word drug shall encompass the term medical devices as it appears in the principal act u/s 3(b) (iv).

His comments include that there should be strict law to prevent the sale and distribution of not-of-standard-quality medical devices as the government cannot in any manner permit such medical devices to be sold and distributed. There is reference about NSQ medical devices in the draft bill.

Since the draft bill suggests for the term ‘drugs control officer’ (DCO) in place of ‘drugs inspector’, it has been suggested to make a change to the officer under section 7H as ‘medical devices control officer’ just as DCO under section 21. He also suggests to the director of health and family welfare that all the officers notified under section 21 should also be notified under section 7H.

Panicker justifies that in both the sections in the draft bill, it is stated as ‘drugs control officer’. During implementation of the Act this can cause problems as an officer appointed under section 7H can act as an officer under section 21 and vice-versa. To avoid this, the name of officer under section 7H should be made ‘medical device control officer’, he pointed out in his proposals.