Ministry of Health and Family Welfare published two draft amendment notifications dated June 23, 2026, under the Drugs and Cosmetics Act, 1940, after consultation with the Drugs Technical Advisory Board — one amending the Medical Devices Rules, 2017, the other amending the Drugs Rules, 1945. Objections/suggestions may be sent to the Under Secretary (Drugs), MoHFW, or emailed to drugsdiv-mohfw@gov.in.

Medical Devices Rules, 2017 (Class B devices):

• Rule 20(5): State Licensing Authority to complete scrutiny and assign Class B applications to notified bodies within 30 days of online submission; rectifiable-deficiency period reckoned from date of removal of deficiencies.
• New Rule 20(5A): Manufacturing site must conform to Fifth Schedule Quality Management System requirements, verified by Notified Body audit before licence grant.
• Rule 20(6)(i): Site audit by registered Notified Body within 30 days of assignment; report submitted to State Licensing Authority.
• New Rule 20(6)(i)(a): Non-conformance found during audit — compliance verification within 20 days of receiving manufacturer’s compliance report.
• Rule 20(6)(ii): Notified Body’s final report with recommendations due within 15 days of audit completion.
• Rule 21(4): “forty five” days replaced with “thirty” days.
• Rule 23(1): “sixty” days replaced with “fifty five” days.
• New Rule 23(3): Non-conformance found during inspection — compliance verification within 15 days of receiving manufacturer’s compliance report.
• Rule 25(1): “forty-five” days replaced with “twenty” days.

Drugs Rules, 1945 (import for analytical/non-clinical testing):

• Rule 33(a)-(e): References to “licensee”/”licence”/”Form 11” extended to include “acknowledgement of prior intimation under proviso to Rule 34(1)”.
• Rule 34: New proviso — import of drugs for analytical and non-clinical testing (excluding sex hormones, cytotoxic, beta lactam, biologics with live microorganisms, narcotic/psychotropic drugs) permitted via online Form 12 application as prior intimation to Central Licensing Authority; import allowed on acknowledgement of such intimation.
• Rule 35: Marginal heading and sub-rule (1) extended to cover prior-intimation acknowledgement; Rule 35(2) substituted — licensee/acknowledgement holder whose licence/acknowledgement is cancelled may appeal to Central Government within 3 months of the order.
• Schedule A, Form 12: Heading and opening paragraph amended to read “LICENCE OR PRIOR INTIMATION”.