Along with the pharmaceutical industry, which implemented new label rules with MRP inclusive of taxes from October 2, the Indian System of Medicine (ISM) drug manufacturers in the country are also moving to a new label regime.

A few months ago, the Department of Ayush had directed the State Governments to ensure all the ASU drugs carry details of ingredients in the labels and the manufacturers are following statutory labeling rules, effective from July 1 2006, as per the provisions of the Drugs and Cosmetics Act Rule 61 (1) and (2).

According to industry sources, a good percentage of the Ayurvedic drug manufacturers in the country have switched over to new labels with ingredient details, in the case of their classical formulations. New batches of medicines manufactured by the industry now follow the rules. The transition would be complete by December in a phased manner.

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 due to practical difficulties, as it is impossible to list all the ingredients mentioned in the classical texts. 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.

As per the new directive, all the manufacturers have to either mention the details of the ingredients on the label itself or have to provide a leaflet containing information on the ingredients and other mandatory disclosures.

Sources said the Department recently diluted the norms and has allowed the manufacturers to display only the compound name, instead of the classical text details. Further, textual reference and details can be made in the case of compounds, which are not mentioned in the official Ayurveda pharmacopoeia or formulary.

Ranjit Puranik, general secretary of Ayurvedic Drug Manufacturers Association (ADMA) said the association has started a campaign among the industry to follow the rules. A meeting attended by about 125 manufacturers was held on 9th September in Nashik and discussed the issues related to the rules. Similar meetings will be soon conducted at Punjab, Kolkota and Bangalore.

He said bi-lingual labels, especially details in local language, is already in vogue in the case of most of the classical Ayurvedic formulations, though it is not mandatory for the ISM sector. Similarly, the industry also follows the MRP regime, as extra local taxes are not levied on ISM medicines.