The Department of Ayush has issued letter to All State Licensing/Drug Controllers of Ayush drugs regarding status of license of grant to herbal juices/drinks. Ayush Department has observed that the herbal juices/drinks bearing Ayurveda, Siddha and Unani (ASU) drug license are available in the market. In this regard, the State Licensing Authorities have been asked to provide the list of all such products which have been given license in a prescribed format.

Licensing of two categories of Ayurveda, Siddha and Unani medicines has been defined in Section 3 (a) and (h) of the Drugs and Cosmetic Act, 1940 and it shall be done strictly according to the regulatory guidelines prescribed in Rule 158-B of the Drugs and Cosmetic Act, 1945. The letter further states that license applications of the product not fulfilling the legal definition of ASU drugs and the requirements of Rule 158-B may not be accepted and license be revoked, if any such product has granted due to oversight of legal provisions.

Section 3 (a) of D&C Act 1940
Ayurveda, Siddha or Unani drug includes all medicines intended for internal or external use for or in the diagnosis, treatment, mitigation or prevention of[disease or disorder in human beings or animals, and manufactured] exclusively in accordance with the formulae described in, the authoritative books of Ayurveda, Siddha and Unani Tibb systems of medicine, specified in the First Schedule.

Section 3 (h) of D&C Act 1940
Patent or proprietary medicine means:

(i) In relation to Ayurvedic, Siddha or Unani Tibb systems of medicine all formulations containing only such ingredients mentioned in the formulae described in the authoritative books of Ayurveda, Siddha or Unani Tibb systems of medicine specified in the First Schedule, but does not include a medicine which is administered by parenteral route and also a formulation included in the authoritative books as specified in clause (a);

(ii) In relation to any other systems of medicine, a drug which is a remedy or prescription presented in a form ready for internal or external administration of human beings or animals and which is not included in the edition of the Indian Pharmacopoeia for the time being or any other Pharmacopoeia authorised in this behalf by the Central Government after consultation with the Drugs Technical Advisory Board constituted under Section 5.

Rule 158-B of D&C Act 1945

158 A. Conditions of loan licence - A licence in Form 25E shall be subject to the following further conditions, namely:

(a) The licence in Form 25E shall be deemed to be cancelled or suspended, if the licence owned by the licensee in Form 25D whose manufacturing facilities have been availed of by the licensee is cancelled or suspended, as the case may be, under these rules.

(b) The licensee shall comply with the provisions of the Act and of the rules and with such further requirements if any, as may be specified in any rules subsequently made under Chapter IVA of the Act, provided that where such further requirements are specified in the rules, these would come into force four months after publication in the Official Gazette.

(c) The licensee shall maintain proper records of the details of manufacture and of the tests, if any, carried out by him, or any other person on his behalf, the raw materials and finished products.

(d) The licensee shall allow an inspector appointed under the Act to inspect all registers and records maintained under these rules and shall supply to the inspector such information as he may require for the purpose of ascertaining whether the provisions of the Act and the rules have been observed.

(e) The licensee shall maintain as inspection book in Form 35 to enable an inspector to record his impressions and the defects noticed.

Concept of herbal juices in Ayurveda
Herbal juices have been defined as Swarasa Kalpana in Ayurvedic pharmaceutics. In Latin, they have been addressed as Succus and expressed juice. Expression is the process by which juice and oils are pressed out of vegetable substances, as in the preparation of Succus, or squeeze out the liquid from the marc as in the preparation of tinctures. Several Swarasa have been mentioned in ancient Ayurvedic texts for preparation of various diseases.

Recently market who has been flooded by commercial preparations of juices and they are being widely prescribed by practitioners. Amla juice, Aloe vera juice, Neem juice, Karela juice and Guduchi Swarasa are household remedies for several diseases. The question is regarding availability of reference in Ayurvedic classics rearing their mode of preparation and medical use. As an instance, reference for Guduchi Swarasa (Amritaswarasa) is available in Ayurvedic classics. We need to pinpoint this point that where references are available in the Ayurvedic classics, those products should be brought under the umbrella of manufacturing.

Regulatory body for ayurvedic nutraceuticals
Nutraceuticals are part and parcel of Ayurvedic subject Bhashjya Kalpana Vigyana. In our vision, we need to create a separate department for the nutraceuticals for Ayurveda. A regulatory body is need of the hour for Ayurvedic nutraceuticals just like CCRAS. Ayurvedic medicine should be reserved for treatment of diseases and nutracceutical should address the preventive part of the disease.

Impact of Ayush letter on manufacturing industry
The letter issued by the Ayush Department regarding status of grant license to herbal juices/drinks shall have positive as well as negative impact on the manufacturing industry. The Ayush department should come with a crystal clear list of references for the safeguard of the genuine manufacturers. When we talk about positive impact on the industry, substandard herbal juices/drinks may fade away to the ease of the genuine manufacturers reaching the masses. Let us remember the FDA alert on Noni juice products.


(Dr. Amritpal Singh is a herbal consultant and Dr. Vikram Chauhan is with Planet Ayurveda, Mohali)