A proposal in this regard has been made by the Ayurveda, Siddha, Unani, Drugs Technical Advisory Board (ASUDTAB) in the draft rules framed by the ministry for the amendment of D&C Rules.
The draft rules to be inserted in the amendment of the Drugs and Cosmetics Rules, 2016 proposes that all the state governments must constitute a ‘State Technical Committee (STC- ASU) for Ayurveda, Siddha and Unani Drugs’ to advise the state government on technical matters related to licensing and quality control of ASU drugs.
In the draft notification issued by the ministry it is clearly mentioned that the committee should consist of experts with post graduate qualifications in either of the ASU category and one each from pharmaceutical chemistry, pharmacognosy, clinical pharmacology and ASU pharmacy.
Once the Committee comes into effect, the state licensing authority should consult the STC for licensing of all the drugs defined under Section 3 (a) of the D&C Act. As per the draft notification, the SLA has to dispose off the application of the manufacturer within two months from the date of submission with all required documents. The STC is constituted under Rule 152 A (6) of the D&C Rules. Further, it is proposed that the SLA should be supported by Drug Testing Lab accredited by the National Accreditation Board or a Laboratory approved under the Drugs and Cosmetics Rules, 1945.
After the amendment of the Rules, the certificate of renewal of a licence in Form 25D will be issued in Form 26D. The application for renewal should be accompanied with year wise detail of the quantity of drug manufactured (batch wise details) during the past three years (in case of first renewal of New Ayurvedic, Siddha or Unani drugs), or past five years (in case of renewal of licence of drugs described under section 3 (a) and section 3 (h) of the Act) along with a consolidated safety report listing side effects, fatalities, injuries etc. related to the drug.
Similarly, the certificate of renewal of a loan licence in Form 25E will be issued in Form 26E.
An original licence in Form 25D or a renewed licence in Form 26D, unless sooner suspended or cancelled, will be valid for a period of five years from the date of its issue or renewal. The original licence issued for drug defined under section 3 (h) for New Ayurvedic, Siddha or Unani drug will be valid for a period of three years from the date of its issue.
The time limit of three months will be substituted by two months and fee of Rs.500 will be substituted by Rs.1000.
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