Subsequent to the Central government’s decision to constitute an expert panel to facilitate export of Indian made traditional products to foreign markets and for grant of licenses for new ASU drugs, a leading Ayush manufacturer from New Delhi has written to the Union Ayush ministry that government should find ways to redress the problems faced by the manufacturers and exporters of Ayush products to the international markets.

In a letter with comprehensive suggestions for the growth of the Ayush industry, Sanjay Srivastva, director of Maharshi Ayurveda Products Pvt Ltd in New Delhi, has urged the government to take immediate steps to upgrade and update the Ayurveda Pharmacopoeia of India to international standards with the current names of the plants.

Sharing his suggestions to the government with Pharmabiz, Sanjay said, provided an initiative from the government side is there for getting the API monograph recognized by as many importing countries as possible, it would prove to be an important step in enabling ayurvedic products getting registered in such countries. Presently, there is no clarity regarding the dosage in APIs. It is not clear that the dosage mentioned in API is a single dose or should be repeated in 24 hours.
 
According to him, now emphasis is being given to standardize the plants and finished products in respect to the identification of marker compounds which is not available in the API. For example, ‘sanay’ (Swarnapatri) is restricted because the Maximum Daily Dose (MDD) must not contain more than 0.001% sennoside. Similar restrictions are being applied to a significant number of herbs. The permitted concentrations are so low that the original plants are in effect banned from use in a medicinal context. So it can be easily understood that the net effect of this procedure is to ensure that pharmaceutical companies are the only ones who can utilize the healing properties of these particular plants. The NHP Bill (Natural Health Products Bill) has already placed restrictions on 95 commonly used ayurvedic ingredients. There is no ayurvedic expertise being applied here.
 
Each country has its own list of permitted herbal ingredients. Many ingredients such as bala, vidang, nishoth, kutaj, punarnava, etc. are either banned or restricted in many countries. The ministry of Ayush should take initiative to provide as many documents or evidences to these countries and should also engage with them at government level to provide sufficient information so that these herbs are permitted for use in ayurvedic formulations, he pointed out.

Further, he mentioned in the letter that the food safety regulations have come out with Gazette Rules proposing ban of sale of healthcare/food supplements as medicines. Currently, ayurvedic companies are exporting products as food supplements in the international market since Ayurveda is not recognized in other countries. FSSAI has also framed rules for products based on Ayurveda, Siddha, Unani and other traditional health care products. Any move by the FASSI to stop the export of ayurvedic products as food supplements in the international market will impact export of such products.
 
Ministry of Ayush should also engage with Directorate General of Foreign Trade (DGFT), Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) and the Wild Life Protection Authorities to come to a consensus as to the use of restricted medicinal plants and product of animal origin that are being regulated under these authorities. Shipments are unnecessarily getting detained at the airport and at the sea ports for want of these from the agencies and they have different interpretations as to what species or forms are restricted/prohibited for use in ayurvedic formulation. For example, as per the Wild Life Authorities, red sandalwood is prohibited under the EXIM policy while CITES allows it to be used in formulation where it is present physically unrecognizable and inseparable form.

According to information received, the Ayush ministry is going ahead with its plan to amend the Drugs and Cosmetics Rules 1945 in the wake of the government’s decision to export Indian made traditional products to foreign markets. Besides, the ministry wants that licences for new Ayurveda, Siddha and Unani (ASU) drugs should be granted only after thorough examination by an expert committee formed for the purpose.

 Sanjay Srivastva is an EC member of the Ayurvedic Drugs Manufacturers of India and also a member of the Pharmaceuticals Export Promotion Council. He is associating with various technical committees under the ministry of Ayush.