The Central Government will soon amend the Drugs & Cosmetics Act 1940 mandating centralized product registration and licensing with the Department of Ayush for all Ayurveda, Siddha and Unani drugs.
As per a copy of the soon to be publicized notification available with Pharmabiz, a new Section 153-B will be added, by which an application for issuance of product registration number for the grant or renewal of a license to manufacture for sale any Ayurvedic, Siddha or Unani drugs as defined in section 3(a) of the Drugs and Cosmetics Act, 1940 shall be made in Form 24-D to the licensing authority, the State drug controllers.
The State drug controllers will examine the application and submit recommendations to the Drug Control Cell of the Department of AYUSH, or any other agency to be constituted for granting product registration number.
This agency will issue the product registration number of each patent or proprietary Ayurvedic, Siddha or Unani drugs to the licensing authority, which shall issue the licences. Each of the applications will be examined by the 'product registration committee,' which will be constituted every two years by the Central Government, said the notification.
Sources said, the notification would virtually take away the licensing powers of the State Drugs Controllers in the case of ISM drugs, though technically, the State Drug Controllers would remain as the licensing authority.
Further, it is proposed to amend the Act to mandate the licensee to maintain the record for shelf life of the product, list of excipients, post marketing surveillance data every year for new patent or proprietary Ayurvedic, Siddha and Unani drugs.
Besides, the notification proposes to amend the labelling rules to specify indication and contraindications (if any), product registration number and date of expiry.
Another proposed amendment is to mandate that 'raw materials used in the preparation of Ayurvedic, Siddha or Unani drugs shall be identified and tested, as per the Ayurvedic, Siddha and Unani pharmacopoeial standards, wherever tests are available for their genuineness and records of such tests as are carried out for the purpose and the methods thereof shall be maintained.
Where the tests are not available, the test should be performed according to the manufacturer's specification or other information available', proposes the notification.