Union government's proposed amendments to the Drugs & Cosmetics Rules early this year has been welcomed by the Ayush industry. The two amendments have been prepared in consultation with the Technical Advisory Board of Ayush.

The new rules under the first amendment of 2008 is known as 157A under the Schedule TA calls to maintain records of the raw materials used by licensed Ayush manufacturing units. Each licensed manufacturing unit will be given a performa to indicate the raw materials utilized in the units. The units will need to submit the list to the State drugs control authority and the National Medicinal Plants Board or any agency nominated by the National Medicinal Plants Board for the purpose.

The performa for record of utilization of raw material by Ayush licensed manufacturing units will make companies indicate the quantity of medicinal plants, extracts, essential oils metals, animal by products used between April 1, 2008 and March 31, 2009.

The Second amendment, which is still a draft refers to section 169 and deals with permissible use of excipients. This has been circulated to the industry for objections and suggestions.

The permitted excipients, which include additives, preservatives, antioxidants, flavouring agents, sweeteners and chelating agents will now need to be used as prescribed in the Indian Pharmacopoeia. It will need to comply with the quality specification and should not exceed any specified limits of usage except hydrogenated vegetable oils.

Only natural colouring agents as permitted under rule 26 of the Prevention of Food Adulteration (PFA) Rules will now be allowed for Ayush drugs. Colours permitted under Rule 127 of Drugs and Cosmetic Act will be used for proprietary Ayush drugs as defined in the sub clause (h) of the section 3 of the Drugs and Cosmetics Act should never exceed any specified limits usage.

Further, the preservatives and labels should be indicted on the labels. The manufacturers should also ensure rationality, safety and quantity used of various excipients used in the formulation.

In the case of additives being used for the Ayush drugs, the manufacturers should clearly mention the quantities used in the application for licenses and maintain the record of the same.

With regard to deletions made in the case of particular preservative or additive referred in the Indian Pharmacopoeia or the PFA, in that case the industry should make the required changes.

The two amendments will help the industry to be recognized for quality practices, stated JSD Pani, president, Karnataka Indian Medicine Manufacturers Association.

Large units engaged in Ayush drug manufacturing already adhere to the practices whereas the medium and small units will now need to abide by the new rules, he added.