As part of bringing in more central control over manufacturing and sales of Ayurveda, Siddha and Unani drugs in the country, the central government will soon amend the Drugs and Cosmetics Act 1945 mandating furnishing of data related to raw material usage to Central and State authorities.
As per draft of the proposed Drug and Cosmetics (Amendment) Rules, 2006, a new rule 157 A, shall be inserted for maintaining of records of raw material used by each licensed manufacturing unit of Ayurveda, Siddha and Unani drugs in the preceding financial year.
The manufacturers will have to submit record in the perform given in Schedule T-I in respect of all raw materials utilized by that unit in the manufacture of Ayurveda or Siddha or Unani drugs in the preceding financial year by the 30th day of June of the succeeding financial year. The data have to be submitted with the State Drug Licensing Authority of Ayurveda or Siddha or Unani drugs and National Medicinal Plants Board or any agency nominated by the National Medicinal Plant Board for this purpose.
Further, Schedule T of the Act has been proposed to be amended, with a Section Schedule T-1 detailing usage of metals/minerals, animal by-products, breakdown of total turnover, shortage of raw material(s)/ inputs etc.
According to industry sources, the two notifications mandating filing of product registration and usage of raw materials with the Central and State authorities will burden the ISM drug units in the country. "We will oppose these notifications as it will cause duplication of records and delay in clearances for the Ayurveda and other ISM manufacturing units," said a senior industry professional.
As reported in Pharmabiz last week, the Centre is also planning to amend the D&C Act mandating centralized product registration and licensing with the Department of Ayush, adding a new Section 153-B.