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Utility of essential drug list for Ayush industry

Dr. Amritpal Singh
Wednesday, January 04, 2017, 08:00 Hrs  [IST]

Essential Drug List (EDL) has been prepared by the Department of Ayush separately for Ayurveda, Unani, Siddha and Homeopathic medicines. There are 277 essential medicines in Essential Drug List of Ayurveda, 257 medicines in Homoeopathy, 302 medicines in Siddha and 288 essential medicines in Unani system of medicine. The Ayush department undertook a year-long exercise to review the lists of essential Ayurveda, Siddha, Unani and Homoeopathic drugs published in the year 2000 and in the process interacted with various stakeholders, including representatives from the fraternity of in-service practitioners, Ayush department officers and procurement authorities from Central and state government organisations.

Comprehensive essential Ayurveda, Unani, Siddha and Homeopathic drug lists presently drawn with cross sectional consultation take into account of pharmacopoeias, formularies and regional preferences for certain medicines and offers wide choice for need-based selection of generic medicines. The Essential Drug List is mandatory in all systems of medicine and is part and parcel of the World Health Organization (WHO) policy. Essential Drug List of traditional medicines is integral part of the WHO policy for traditional medicines.

Requirement of Essential Drug List
Essential Drug List incorporates information on ingredients with quantity, disease indication, dose and vehicle for Ayurvedic formulations. The pattern of information presented in the Essential Drug List is typical for Ayurvedic formulations. The publication of the official document related to Essential Drug List for Ayurveda is a welcome and timely step for the Ayurvedic drug industry. The document is available on the official website of the Department of Ayush and can be downloaded from the link www.ayush.gov.in.

The Ayurvedic drug industry is highly unorganized sector. Keeping in mind the vast number of crude herbal/natural drugs used in designing formulations, it is not easy to cultivate and procure each and every crude drug. To meet the daily requirements, the Ayurvedic drug manufacturers use adulterants in designing formulations. Essential Drug List of Ayurveda should be made compulsory document so as to ensure genuine manufacturing of classical Ayurvedic formulations.

Legality of Essential Drug List
Till to date it is not mandatory that the Essential Drug List should be a reference guide for the Ayurvedic drug industry. Ayurvedic Pharmacopoeia of India (API) and Ayurvedic Formulary of India (AFI) are two official publications followed by the Ayurvedic drug industry for guidance. The majority of the ayurvedic drug manufacturing houses are not aware about the Essential Drug List published by the department of Ayush.

The need of the hour is to make ayurvedic drug industry conscious about the recent developments and the department of Ayush should send communication at State level for adopting the Essential Drug List as a mandatory reference guide by the industry.

Essential Drug List and Drug & Cosmetic Act
Adoption of the Essential Drug List by the industry can play a significant role in establishing provisions of the Drug and Cosmetic Act applicable to traditional/ayurvedic medicines. Recently, the department of Ayush has made several amendments in the Drug and Cosmetic Act so as to enhance the acceptability and credibility of Ayush among masses.

Various schedules related to Ayush industry are enumerated for benefit of the reader
•    First Schedule substituted by act 13 of 1964 came into force w.e.f 1-2-1969. The schedule lists the standard Indian pharmacopoeias to be followed for manufacturing Ayurveda, Siddha and Unani drugs. About 57 books of Ayurveda (with insertions in 1987, 1994, 2002), 29 of Siddha (1987), 13 of Unani Tibb systems are listed.
•    Second Schedule came into force w.e.f 15.09-64. It states about the standard to be complied for manufacturing drugs. (Subs. by Notifn. No. G.S.R. 885, dated the 4th August, 1973, Gazette of India, Pt. II, s. 3(i), p. 1643.)
•    Schedule E(1): List of poisonous substances under the Ayurvedic (including Siddha) and Unani Systems of Medicine (Added by Notfn. No. 1-23/67-D dated 2-2-1970) differentiated into vegetable, animal and mineral origin.
•    Schedule T: Good Manufacturing Practices (GMP) for Ayurvedic, Siddha and Unani medicines. (Ins by G.S.R. 561 (E) dt 23-06-2000 and subs. by G.S.R. 198(E), dt. 7.3.2003.). Under Schedule “T” of the drugs and cosmetics act 1940, the government has made it mandatory for all manufacturing units to adhere to good manufacturing practices.

Rules
•    Rules: Part XVI (Parts XVI, XVII and XVII added by S.O. 642, dated 2-2-1970 (with effect from 21. 2. 1970) Manufacture for sale of Ayurvedic (including Siddha or Unani drugs). It notifies about how to acquire licenses, loan for establishing a unit and also on the identification of raw materials and its purity.
•    Part XVIA: Approval of institutions for carrying out tests on Ayurvedic, Siddha and Unani drugs and raw materials used in their manufacture on behalf of licenses to manufacture for sale of Ayurvedic, Siddha and Unani drugs (Ins. by G.S.R. 701(E), dated 27-7-2001 and subs. by G.S.R.73 (E), dated 31-01-2003.)
•    Part XVII: Labelling, packing and limit of alcohol in Ayurvedic (including Siddha) or Unani drugs. (Subs. by G.S.R. 904(E), dt. 2.11.1992.)
•    PART XVIII: Government analysts and inspectors for Ayurvedic (including Siddha or Unani drugs).
•    PART XIX: Standards of Ayurvedic, Siddha or Unani (Ins. by G.S.R. 519(E), dated 26.6.1995.)

Essential Drug List and Objectionable Advertisement Act
The Essential Drug List describes the specific diseases in which classical Ayurvedic formulations are indicated. If the Essential Drug List is made legal document for the Ayush industry, it can help in curbing malpractices being adopted by the substandard pharmacies for promotional purposes. Many pharmacies are claiming cure for incurable diseases and this is a gross violation of the provisions of the Objectionable Advertisement Act.

(Author is a herbal consultant, based in Mohali)

 

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