Annoyed with the lack of pro-activeness in genuinely addressing the issues of the sector, the medical devices industry has expressed severe angst over incompetency of the CDSCO over regulating the medical devices sector.  This outburst comes in the wake of the failure of the Centre in delinking Schedule M of pharmaceuticals from Schedule M III for medical devices in Rule 76, in spite of repeated representations.

In a recent draft notification with reference No. GSR 11(E) that was released by the health ministry in January, there seems to be an error in drafting the amendment of Rule 76. Instead of deleting only the word 'and' from Schedule M (and Schedule M III in respect of medical devices) erroneously, the government has deleted 'Schedule M and'.  Further complicating the matter for the industry is the fact that the notification retains sub clause (2) and sub clause (3) of Rule 76 which is still applicable to all the drugs specified in rule 76 including medical devices.

“What we wanted is deletion of reference of Schedule M-III from sub clause (2) & (3) of Rule 76 and addition of sub clause (3)a for medical devices. But the government has resorted to tactics to prolong their control over the medical device sector even though they do not have the expertise nor the manpower to do so. This attitude is having a huge impact on the industry and we want the government to take cognizance of this fact at least now,” stressed, Rajiv Nath, forum coordinator of Association of Indian Medical Device Industry (AIMED).

He further pointed out that though the government did take some measures in the micro level, their main demand for amending rules and schedule different from drugs have still not been considered. The industry has been demanding the Centre to define GMP compliance as per IS:15579/ISO 13485 and delink Schedule M of Pharmaceuticals from Schedule M III for medical devices in Rule 76.

However, AIMED pointed out that the government has again failed to address their demand and in fact have tried to misrepresent and masquerade the whole process further, to confuse the industry. Nath said that this attitude of the government stands testament to their intention to continue to regulate medical devices like pharmaceuticals, which should not be the case.

Schedule M specified for pharmaceuticals has four elements namely, good manufacturing practices (GMP), requirement of premises, equipment and plant. While,  Schedule M III for medical devices defines only one element i.e. requirement of premises. Nath pointed out that what is critical and missing is GMP and the quality management system (QMS) which the industry wants to be restricted to only IS: 15579.

Nath informed that to comply with this 20 page BIS document which includes eight clauses and then additionally expect manufacturers to comply with a 57 pages draft Schedule M III detailed document with 29 Schedule as for Schedule M for devices and additionally 33 clauses in diagnostics, is an excessive burden for a manufacturer with engineering and no pharmaceutical background.

“If this gets implemented we fear that the excessive overkill will scare of investment in this import dependent sector. We are going in circles and a simple task to encourage make in India is needlessly getting complex and delayed. All we want from the government is to refer entire copy of BIS: 15579 w.r.t. GMP only, rather than to relate clause by clause Schedule M III to BIS 15579/ ISO 13485 for specific requirements,” informed Nath.