amend D&C Rules of AYUSH

Ayush ministry to amend D&C Rules to mandate clear cut shelf life for all Ayurveda, Siddha & Unani drugs

Peethaambaran Kunnathoor, Chennai Thursday, January 28, 2016, 08:00 Hrs  [IST]  (PhamaBizz.com)

The Union ministry of Ayush is considering certain strict mandates with regards to the shelf life/date of expiry of Ayurveda, Siddha and Unani (ASU) drugs, for which the ministry is going ahead with plans for amending the Drugs and Cosmetics Rules, 1945.

After the amendment, the clauses stating expiry dates of ASU drugs in D&C Rules, 1945, will be known as ‘the Drugs and Cosmetics (seventh amendment ) Rules, 2015’. In it, the rule 161-B will be substituted as, ‘161B, shelf life or date of expiry of medicines’.
The sub rule 161 B will be applicable for granting licence or renewal of licence for manufacturing after the date of notification of the rules. It is expected that it will come in force from the date of their final publication in the official gazette. The draft of the rules was published on November 24, 2015 for discussion among the stakeholders.

The published draft rules mandate that there should be clear cut expiry dates for all ASU drugs, and after the prescribed date of expiry, no licensed ASU medicine can be marketed, sold or distributed. Further, the date of expiry of Ayurveda, Siddha and Unani medicines should be conspicuously displayed on the label of the container or the package.
The sub rule will seek the scientific data based shelf life or date of expiry of the medicines based on the studies of medicines in accordance with the guidelines prescribed in the Ayurvedic, Siddha or Unani pharmacopoeia. This scientific data should be submitted to the state licensing authority (SLA) by the person applying for licence or renewal of licence for the manufacturing of ASU medicines defined under clause (h) of section 3 of the Act. However, this sub rule will be applicable after three years from the date of notification of the rules, according to sources from the Ayush ministry.

The SLA, before granting licence or renewal of licence, has to ensure the validity of the data submitted by the manufacturer in support of the claimed shelf life of his medicine. The SLA has the right to ask for samples of medicines and any other related information from the manufacturer at any time, and can share it with the pharmacopoeial laboratory for Indian medicine, Ghaziabad, for analysis or independent validation.

On failure of providing the details by the manufacturer, the SLA can suspend the manufacturing licence.