Regulation of manufacture and sale of ASU drugs

Ever since independence in 1947 there has been a sustained policy support for the development of Indian Systems of Medicine and Homoeopathy. Government has taken a number of legislative and administrative measures to regulate the manufacture and sale of Ayurveda, Siddha and Unani (ASU) drugs. There is a separate Chapter IVA which regulates the manufacture and sale of ASU medicines in the Drugs & Cosmetics Act, 1940. Chapter IVA of the Indian Drugs & Cosmetics Act, 1940 has provisions for regulation of manufacture and sale of ASU drugs, packaging and labelling of ASU drugs for domestic use and export and penalty for manufacture and sale of ASU drugs in contravention of these rules and for misbranded, adulterated and spurious ASU drugs.

The Act is enforced through the State Drug Licensing and Drug Control Authorities. A separate Ayurveda, Siddha and Unani Technical Advisory Board (ASUDTAB) has been constituted by the Central Government comprising of officials and nominees of Central Government, pharmacogonists, Phytochemists and Members of the Ayurveda Pharmacopoeia Committee, Siddha Pharmacopoeia Committee and Unani Pharmacopoeia Committee and representatives of teachers, practitioners and ASU Drugs industry nominated by the Central Government to advise the Central and State Governments on technical matters relating to regulation of ASU drugs. The Central Government has also constituted a Ayurveda, Siddha and Unani Drugs Consultative Committee (ASUDCC) under the Act to advise the Central and State Governments and the ASUDTAB on any matter for the purpose of securing uniformity though out India in the administration of Drugs & Cosmetics Act, 1940 as it relates to ASU drugs. Periodic meetings of these statutory bodies are held and all technical and regulatory issues arising out the enforcement of Chapter IVA of the Drugs & Cosmetics Act, 1940 relating to ASU drugs are referred to these bodies for advising the Central and State Governments. A specific law, the Drugs & Magic Remedies Act, 1954, is also in place for prevention of objectionable advertisements & publicity relating to certain drugs and magic remedies for treatment of certain identified diseases and disorders.

Laying down of pharmacopoeial standards of drugs are mandatory as per Drugs & Cosmetics Act, which was amended in 1964 to bring under its purview Ayurveda, Siddha and Unani drugs. For implementation of the Act and Rules thereunder, and as a first step the Pharmacopoeial Laboratory of Indian Medicine (PLIM) was set up in 1970 and the Homoeopathic Pharmacopoeial Laboratory (HPL) was set up in 1975 to facilitate drug standardization & testing of ASU drugs. In addition 13 other reputed laboratories have been engaged to lay down pharmacopoeial standards and preparation of monographs and for evolving Standard Operating Procedures (SOPs) for ASU drugs. Pharmacopoeial Committees have been constituted separately for ASU systems. It is the responsibility of these Committees to lay down standards of quality, purity and strength of drugs and approve drug formularies. So far, 326 monographs of Ayurveda drugs in 4 volumes, 45 of Unani drugs, 916 of Homeopathic drugs have been published. Another 98 monographs on Ayurveda drugs are due for publication very soon. Formularies of Ayurveda, Siddha and Unani containing 636, 248 and 745 multi-ingredient classical formulations respectively have been published to facilitate manufacture of drugs with uniform composition and manufacturing procedures.

Parameters adopted for Quality control & Standardization

Ayurveda, Siddha and Unani drugs which are mainly poly-herbal/herbo-mineral preparations are very different from synthetic molecules of the allopathic system which are produced under controlled laboratory conditions. Much depends on the quality and availability of raw materials of botanical origin. Keeping this in view, the National Medicinal Plants Board (NMPB) was established in the year 2000 with the objective of in-situ conservation and ex-situ cultivation of quality medicinal plant raw materials. In view of environmental pollution the NMPB is examining how best to adopt Good Agricultural and Collection Practices for collection and cultivation of medicinal plants for ensuring quality raw material for ASU medicines. As a large number of our forest dwellers and small landholders are engaged in collection and cultivation, these norms have to be adopted in a way that livelihood is not affected.

Both traditional and modern parameters are used for quality testing and standardization of raw materials as well as finished products. Many methods from organoleptic standardization of drugs, chemical analysis, biological assaying for testing of heavy metals, pesticides and microbial load have been developed for quality control and standardization of ASU drugs. An effort has been made to include Chromatographic fingerprint profile as a supplementary to Ayurvedic Pharmacopoeia. Identification of active therapeutic ingredients and marker compounds with reference to which ASU drugs can be standardized are still evolving and all these parameters are being added to the ASU pharmacopoeia. Pharmacopoeial Laboratories and laboratories of Central Council for Research in Ayurveda and Siddha (CCRAS), Central Council for Research in Unani Medicine (CCRUM), various laboratories of Council for Scientific & Industrial Research (CSIR) and private sector institutions and laboratories are doing a commendable job in evolving and laying down safety and quality standards for poly-herbal/herbo-mineral preparations including plant extracts. It needs to be emphasised that the work of quality control and standardization of herbal/herbo-mineral drugs is much more complex and standards are constantly evolving and this is not only true for ASU drugs, it is equally so in other traditional systems of medicine all over the world. While there is a need to speed up this work and for streamlining regulatory mechanism for ASU drugs, it will be inappropriate to term Ayurveda, Siddha and Unani drugs industry as being completely unregulated. It needs to be kept in mind that humanity has survived on traditional medicinal knowledge for thousands of years.

The following major initiatives have been taken by the Central Government for ensuring safety and quality control of ASU drugs:

(i) Good Manufacturing Practices (GMP) for ASU drugs were notified on 23rd June, 2000 under Schedule ‘T’ of the Indian Drugs & Cosmetics Act, 1940 and Rules, 1945 which seeks mandatory compliance from the licensed manufacturers with regard to raw-materials, manufacturing area, manufacturing processes, record keeping, storage of raw-materials and finished products and quality testing. State Governments and all State Licensing Authorities have been advised vide Department of AYUSH order dtd. 13.10.2005 to ensure strict compliance of GMP by ASU drugs manufactures and cancel the license of non-GMP compliant units.

(ii) Provisions relating to proper labelling, packing and conspicuous display of all the ingredients along with the quantities contained in the formulations on the label/container or a leaflet inserted inside the container, have been reiterated for compliance by an order issued by the Department of AYUSH on 10.10.2005 for strict compliance by State Drug Controllers/Licensing Authorities.

(iii) To address domestic as well as international concerns on presence of heavy metals in ASU drugs exporters of purely herbal ASU drugs have been directed to either conspicuously display on the container of purely herbal ASU drugs words “Heavy metals within permissible limits” or furnish the above certificate from an appropriately equipped in-house laboratories or any other approved laboratories along with other consignment papers w.e.f. 1.1.2006. Mandatory testing for heavy metals on purely herbal ASU drugs will also be extended for sale of purely herbal ASU drugs within the country in phases keeping in view the testing infrastructure within the country.

(iv) The issue of safety of herbo-mineral/herbo-metallic Bhasmas/Compounds is also being addressed by the Central Government. A project has been sanctioned for chemical analysis and safety studies of eight most widely used Rasaushadhis/Bhasmas, namely, Kajjali, Rasmanikya, Nag Bhasma, Rasasindoor, Basantkusumkar Ras, Arogyavardhini Vati, Mahayograj Guggul and Mahalaxmi Vilas Ras by CSIR laboratories under the Golden Triangle Project within a time frame of 18 months.

(v) Use of permissible excipients, preservatives for increasing the shelf-life of ASU drugs has been notified. Draft rules for expiry date of ASU drugs have also been published in November, 2005 and a consultation process is on for finalizing these rules.

(vi) Certain guidelines have also been issued to State Licensing Authorities with a view to curb the mushroom growth of irrational ASU combinations through the patent and proprietary route.

As mentioned above the issues concerning quality control and standardization of ASU drugs are very complex and very different from those concerning regulation of synthetic molecules produced under controlled laboratory conditions. This is a problem which is being faced by the regulators of traditional systems of medicine all over the world. Scientific methods and techniques for standardization and quality control of herbal/herbo-mineral drugs are constantly evolving all over the world. Regulators have to keep pace with the development taking place in the field of Botany, Phyto-chemistry, bio-chemistry. Apart from public and private sector research institutions ASU drug industry itself is making an important contribution in the field of evolving methods and standards for drug standardization and quality control. Many private sector companies in India have made a notable contribution in the field of evolving standards and preparation of monographs on herbal plant extracts. Ministry of Health and Family Welfare, Department of AYUSH, apart from laying down pharmacopoeial standards and issuing guidelines under the Drugs & Cosmetics Act and Rules from time to time, has initiated a process of consultation between Ayurveda, Siddha and Unani experts and experts in the field of Botany, Phytochemistry, Bio-chemistry and representatives of ASU drugs industry for making the regulatory framework responsive to the developments in the field of science and technology. It is as a result of these measures that use of techniques like Chromatographic fingerprint profiles and use of active therapeutic ingredients and marker compounds for standardization and quality control of herbal and herbo-mineral preparations are becoming popular in the ASU drugs industry.

The Department of AYUSH will, in consultation with all concerned, come out with more detailed guidelines for licensing of classical and patent & proprietary ASU medicines based on a product dossier system very shortly with a view to further improve and strengthen the licensing framework for ASU drugs.

The Department would like to reiterate that there are regulatory mechanisms in place for regulating standardization and quality control of ASU drugs and the regulatory framework is evolving in response to the developments in the field of science and technology. However, the general public should use ASU medicines as far as possible under medical supervision and they should be purchased on Cash Memos after proper verification of the ingredients mentioned on the label or on the leaflet inserted inside the container. In case of doubt, they should consult a qualified Ayurveda/Siddha/Unani practitioner and any contravention with the labelling provisions should be brought to the notice of the District and State Health Authorities and the Department. ASU Drug Industry Associations should also motivate their members to move in the direction of self regulation and self-certification and as a first step, start voluntarily printing indications and contra-indications of every formulation either on the label/container or in a leaflet to be inserted in the container for educating the general public regarding their products. All queries to the Department can be e-mailed on [email protected] or [email protected]

January 10, 2006