India Plans to Bring All Medical Devices Under CDSCO Oversight in December
The Indian government is planning to give the Central Drugs Standard Control Organization (CDSCO) oversight of the import, manufacture and sale of all medical devices in December. If finalized, the change would require many more medical device companies to seek certification and authorization.
India has been slowly bringing more medical devices under the drugs rules in recent years, starting with high-end products such as imaging equipment. In April, the Drugs Technical Advisory Board (DTAB) signed off on a major expansion of the move to treating devices as drugs, drafting legislation that would require companies that import, make and sell products including contraceptives and certain disinfectants to seek certification and authorization from the national regulator.
The Indian government recently published the draft legislation created by DTAB. The draft is open for comment for 30 days, but the government expects to take little time to review the feedback. Under the current plan, the changes will take effect on 1 December.
DTAB proposed starting to treat the devices as drugs 18 months after the release of the legislation. The advisory board also set out a staggered, risk-based timeline for complying with requirements related to the change and discussed the potential for companies to obtain exemptions. The notice issued by the government, and shared by CDSCO, lacks these details.
Adoption of the timeline proposed by DTAB would have given industry and CDSCO time to adapt to the changes. At the April meeting, DTAB presented the regulatory change as a major undertaking for CDSCO. DTAB proposed creating a new drugs controller position to oversee a team of 449 medical device regulatory officials, most of whom would hold the rank of drugs inspector (medical device) or assistant drugs inspector (medical device).
DTAB also listed 305 laboratory positions and 31 experts and specialists it advised hiring on a contract basis. The result is an almost 800-strong team. Finally, DTAB advised adding staff and infrastructure at the state level to support the increased oversight of medical devices.
India has been slowly bringing more medical devices under the drugs rules in recent years, starting with high-end products such as imaging equipment. In April, the Drugs Technical Advisory Board (DTAB) signed off on a major expansion of the move to treating devices as drugs, drafting legislation that would require companies that import, make and sell products including contraceptives and certain disinfectants to seek certification and authorization from the national regulator.
The Indian government recently published the draft legislation created by DTAB. The draft is open for comment for 30 days, but the government expects to take little time to review the feedback. Under the current plan, the changes will take effect on 1 December.
DTAB proposed starting to treat the devices as drugs 18 months after the release of the legislation. The advisory board also set out a staggered, risk-based timeline for complying with requirements related to the change and discussed the potential for companies to obtain exemptions. The notice issued by the government, and shared by CDSCO, lacks these details.
Adoption of the timeline proposed by DTAB would have given industry and CDSCO time to adapt to the changes. At the April meeting, DTAB presented the regulatory change as a major undertaking for CDSCO. DTAB proposed creating a new drugs controller position to oversee a team of 449 medical device regulatory officials, most of whom would hold the rank of drugs inspector (medical device) or assistant drugs inspector (medical device).
DTAB also listed 305 laboratory positions and 31 experts and specialists it advised hiring on a contract basis. The result is an almost 800-strong team. Finally, DTAB advised adding staff and infrastructure at the state level to support the increased oversight of medical devices.
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