The Union Ministry of Health and Family Welfare has amended the rules for homoeopathic hair oils sold under Schedule K of the Drugs and Cosmetics Act, 1945, by omitting the sub-item Arnica Montana Hair Oil from the existing rules and including Homoeopathic hair oils having active ingredients up to 3X potency as a new item.

In a notification issued in the end of December, 2009, the ministry states that the term in item number 31 of the Drugs and Cosmetics Act, 1945, under the column class of drugs the sub-item (a), relating to 'Arnica Montana Hair Oil' shall be omitted . Instead, the item - homoeopathic hair oils having active ingredients up to 3X potency only - shall be included, which will in turn readjust the range of products coming under the regulation.

The amendment makes the products in the category to be covered with a sale licence in Form 20C, subject to the condition that such a product has been manufactured under a valid manufacturing licence and sold in the original scaled packing of the licensed manufacturers, according to the notification.

Earlier, all the homoeopathic hair oil products using Arnica as basic ingredient was under the purview of the rules made under Schedule K. However, marking the gallop to 3X potency will now exclude the products using mother tincture as basic ingredient, say industry experts. Meanwhile, the amendment will extend the range of products coming under the purview of the rule, as it will also be applicable to products using other active ingredients including Jaborandi extract.

"In Homoeopathy, we cannot say that only a particular ingredient will work on the given target. Including the term 'homoeopathic hair oils having active ingredients up to 3X potency' will include any form of hair oil falling under the system," said an industry expert. However, he refused to comment on the impact of the amendment, explaining that he has not seen the notification. Interestingly, a higher official from the Department of Ayush related to the system also revealed that he is not aware about the development.

The specification of Arnica Montana hair oil in the Act has been a subject of controversy in the industry for some time, as there were lobbying to include specific combinations and strengths of the products in the Schedule K to support certain companies, added the sources. The hair oil segment, which is occupied by several small scale manufacturers, offer a huge potential for players in the Indian Systems of Medicine (ISM) and the implications of the new rule will be known only later, they added.