The Department of Ayush has directed all State Governments to ensure all the Ayurveda, Siddha and Unani drugs carry details of ingredients in the labels and the manufacturers are following statutory labelling rules, effective since 1st July 2006.
Though many of the patent and proprietary medicines of the ISM sector were following the rules, including display of ingredient details, the classical formulations were so far exempted from this provision. The manufacturers of Ayurvedic, Siddha or Unani medicines were exempted to list the ingredients on the product, and instead had to make a reference of the recipe used in ancient texts on the label. With the new directive, all the manufacturers will have to either mention the details of the ingredients on the label itself or will have to provide a leaflet containing information on the ingredients and other mandatory disclosures.
As per the provisions of the Drugs & Cosmetics Act Rule 61 (1) and (2), it is necessary to have 'conspicuous display' on the label of the container or package of an Ayurvedic (including Siddha) or Unani drug, the true list of all the ingredients used in the manufacture of the preparation, together with the quantity of each of the ingredients. A reference to the method of preparation as detailed in the standard text and Adikarana, as prescribed in the authoritative books specified have to be displayed in the labels.
In case the list of ingredients contained in the medicine is large and cannot be accommodated on the label, the same may be printed separately and enclosed with the packing and reference be made to this effect on the label. The container of a medicine for internal use and is made up from a substance specified in Schedule E(I) of the Drugs Act, shall be labelled conspicuously with the words 'Caution: to be taken under medical supervision' both in English and Hindi languages. Further, details like the name of the drug, net content in terms of weight-measure or number, name and address of the manufacturer, license details, distinctive batch number, the date of manufacture etc. have to be displayed on the label.
Industry sources said the new directive, issued a few weeks ago, would cause many hardships to the industry. "Though it is a progressive step for the betterment of the industry, this could cause many hardships to the manufacturers. Manufacturing costs will increase because of the new labelling norms. Most of the herbs used in Ayurveda drug manufacturing are known by their regional names than by their scientific names, and it vary from one state to another. In that case, a manufacturer selling in various states will have to print labels accordingly," Ranjit Puranik, general secretary, Ayurvedic Drugs Manufacturers Association told Pharmabiz.
Dr.D.Ramanathan, general secretary of the Ayurvedic Medicine Manufacturers Association of India (AMMOI) said the new directive would badly hit the Kerala Ayurveda drug manufacturers and would cause increase in drug prices, especially classical formulations. "Already the sales of classical formulations, the strength of Kerala Ayurveda, have gone down marginally in the recent years due to the shift in manufacturing to tablets and capsules. The new norms will cause an increase in prices of these medicines by at least Rs 3 per unit. Many drugs are manufactured with a long exhaustive list of ingredients as per the classical texts and it is difficult to display all the details on the labels," noted Ramanathan.
Sources said the rule would be applicable for the ASU drugs that are manufactured only after 1st July 2006, and the department has directed the state Governments to ensure strict compliance since then.