The manufacturers of Indian System of Medicines (ISM) in Tamil Nadu and Kerala are up in arms against the Ayush department's recent decision under which certain additional details about ingredients of ISM formulations on their labels will be made mandatory from November, 2013.

The ISM manufacturers and the technical experts argue that if the Rule 161 of the Drugs & Cosmetics (D&C) Rules is implemented by the authorities, it will put the industry in a great difficulty. The Rule 161 demands specific information about all ingredients of a formulation such as local name, botanical name and the parts used on the strip/label of the products.

Annoyed over the Ayush department's decision, the manufacturers of siddha, ayurveda and unani medicines in Tamil Nadu will shortly approach the union government requesting them to reconsider the decision as it will not serve any purpose, but help for duplication, said a senior technical expert and advisor to the manufacturers association in Chennai. He said the notification of the Ayush department on November 26 last year is likely to cause a legal tussle between the department and the ISM industry because except one or two companies in the state no other manufacturing unit is capable to follow the norms.

“The label pasted on the formulation is small in size/strips. It is difficult to print all the information about the contents of the medicine in a small label. Instead we can submit this information to the licensing authorities when we apply for a licence. Further we will update our websites with all the information about the manufacture of all formulations which will help the consumers to get an understanding about the details of the medicine,” said Dr T Thirunarayanan, the ISM technical expert in Tamil Nadu.

He said many number of steps are involved and many solvents, catalysts and chemicals are used while isolating an allopathic molecule. These are not fully mentioned on the label of an allopathic product or not even insisted. So the government’s decision insisting on Rule 161 is a discrimination against ISM medicines.

Stiff opposition has also come from the Ayurvedic Medicine Manufacturers Organisation of India (AMMOI) in Kerala. Dr D Ramanathan, president of the AMMOI responded that the decision of the Ayush department would bring down the ayurvedic industry in the country into a zero level growth. The efforts to bring the Indian system into the level of western modern medicine will not fetch any result. If the Rule is implemented, the number of ayurvedic units will decrease from 9000 to 900 in the country. Dr Ramanathan asked the Ayush department to withdraw from the present decision in order to save the ISM industry in the country. AMMOI will submit a memorandum to the department in February first week raising this demand, he told Pharmabiz.