Manufacture of Ayurvedic Medicines – Regulatory Aspects
Table of Contents:
Emergence of Regulatory Activity
Manufacture of medicinal products was not a regulated activity in the developed world in the early days. Then industrial-scale production and mass transportation were applied to medicine manufacturing, and customers could no longer be assured of the quality of products. Consequently, the adulteration of food and drugs became a problem. During the Mexican War (1846-1848) it was found that American troops were supplied with substandard imported medicinal products. This resulted in the passing of the first federal law dealing with medicinal products - the Drug Importation Act of 1848. The unhygienic conditions prevailing in the meat packing industry gave rise to public outcry about the safety of food, and also of the quality of medicinal substances. The death of a dozen children in 1902 from contaminated vaccines forced legislators to pass the Biologies Control Act of 1902, which called for the licensing of biological products and their production in licensed facilities. The Pure Food and Drug Act of 1906 prohibited the mislabeling and adulteration of medicinal products and introduced the U.S. Pharmacopeia and the National Formulary as official standards. This ushered in an era of regulated industrial manufacture of medicines (Dumitriu 1997).
Early Days of the Ayurveda Industry
Up to the first half of the 19th century, a number of households produced and distributed ayurvedic medicines. The production and distribution were not based on principles of modern business management. The production of medicine was concentrated in and around the vaidya’s residence, and the service and production costs were not clearly distinguished. Ayurveda was active in most of the Indian villages, as modern medical systems had not made inroads into rural India. The demand for ayurvedic medicines shot up in the mid-19th century when vaidyas responded to the spread of epidemics like cholera and smallpox. While responding to these problems in the 1880s, bold attempts were made by some vaidyas to shift from household production to bulk production (Harilal 2009).
The first initiatives in large-scale medicinal production were seen in the late-19th century in Bengal. Vaidya Gangadhar Ray in Bengal was inspired by the increasing demand for ayurvedic medicines. He set up a large-scale manufacturing unit in 1884 called N.N. Sen and Company (Gupta 1976). Vaidyaratnam P.S. Variar started the industrial manufacture of ayurvedic medicines in Kerala, in southern India. These attempts later spread to other parts of the country. Manufacturing in Ayurveda passed from small-scale physician outlets to petty/cottage production, and later to the industrial scale, emerging as a competing alternative to the biopharmaceutical market (Harilal 2009).
Drugs and Cosmetics Act, 1940
The Government of India enacted the Drugs and Cosmetics Act, 1940, to regulate the import, manufacture, distribution and sale of drugs and cosmetics (Anonymous 2016a). This Act was initially intended for chemical drugs. However, in 1969, a separate chapter relating to Ayurveda, Siddha and
Unani drugs was inserted by Act 13 of 1964. The laws are more or less similar to those intended for pharmaceuticals. This Act was again modified in 1983, 1987, 1994 and 2002. The Act ensures that the drugs and cosmetics sold in India are safe, are effective and conform to quality standards. It has four Schedules and five Rules related to the Ayurveda, Siddha and Unani systems. The Drugs and Cosmetics Rules, 1945, contains provisions for the classification of drugs under various Schedules and the guidelines for the storage, sale, display and prescription of each scheduled drug (Saroya 2016a).
The First Schedule came into effect on 1 February 1969. It lists the standard scriptures of Ayurveda to be followed for manufacturing Ayurveda, Siddha and Unani medicines. Fifty-seven books of Ayurveda (with additions in 1987, 1994, 2002) are listed in this Schedule (Table 2.1). The Second Schedule came into force on 15 September 1964. It set the standards to be complied with for manufacturing medicines. Schedule E (1) lists the poisonous substances under the Ayurvedic, Siddha and Unani Systems of Medicine differentiated into drugs of vegetable, animal and mineral origin. The fourth Schedule, Schedule T, deals w'ith Good Manufacturing Practices (G.M.P.) for Ayurvedic, Siddha and Unani medicines. The government has made it mandatory under Schedule T of the Drugs and Cosmetics Act 1940, for all manufacturing units to adhere to G.M.P. (Anonymous 2016a).
Part XVI deals with manufacturing of Ayurvedic, Siddha or Unani medicines. It details the procedures to acquire licenses, loans for establishing a manufacturing unit and also the identification of raw materials and their purity. Part XVIA is about the approval of institutions for carrying out tests on Ayurvedic, Siddha and Unani medicines and raw materials used in their manufacture. Part XVII defines labeling, packing and limits of alcohol in these products. Part XVIII lists government analysts and Inspectors for Ayurvedic, Siddha or Unani medicines. Part XIX sets standards for Ayurvedic, Siddha or Unani medicines (Anonymous 2016a).
The First Schedule
Other Applicable Acts
In addition to the Drugs and Cosmetics Act, 1940, a few other important Acts are also applicable to the manufacture of Ayurvedic medicines in India.
The Pharmacy Act, 1948
Passed in 1948, the Pharmacy Act was amended in 1959 and in 1976. Under the provisions of this Act, the Government of India established the Pharmacy Council of India. Pharmacy courses conducted in the country are subject to the approval of the Council under each State Government. A State Pharmacy Council has to be established, and it has the responsibility to maintain a register of pharmacists of the concerned state. The Central Council makes regulations as to the standard of education required for qualification as a pharmacist and prescribes the nature and period of study to be undergone by the pharmacists (Anonymous 2019a).
The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954
This Act prohibits a person from advertising any drug which suggests that the drug can be used for the prevention of miscarriage or conception in women, the maintenance or improvement of the ability of a person to indulge in sexual activity, the correction of menstrual disorders and the diagnosis, treatment or prevention of venereal diseases and so on. It also prohibits giving false information or making claims regarding the true character of a drug (Anonymous 2019b).
The Narcotic Drugs and Psychotropic Substances Rules Act, 1985
This Act makes provisions for the control of operations related to narcotic drugs and psychotropic substances. Psychotropic substance means any substance, natural or synthetic or other material, included in the list of psychotropic substances under the Act. The Act provides for severe punishments to those who contravene its provisions (Anonymous 2019c).
The Poisons Act, 1919
The Poisons Act, 1919, restricts the importation, possession and sale of specified poisons mentioned under the Act. It provides for the collection of excise duty on medical and toilet preparations containing narcotics or narcotic drugs such as alcohol and opium. The list of ayurvedic preparations which can be consumed as alcoholic beverages is specified in the Act (Anonymous 2019d).
The Drugs (Price Control) Order, 1995
The Drugs (Price Control) Order, 1995, replaces the earlier Order of 1987. It is applicable more to synthetic medicines. The Government of India, under the Act, has the power to fix leader prices for the medicines. These leader prices shall operate as the ceiling sale prices for every manufacturer. The Government has the power to fix the manufacturer’s price, retail price and trade commission of certain formulations. Those who violate the provisions of the order are prosecuted under the order and the provisions of the Essential Commodities Act, 1955 (Anonymous 2019e).
The Trade Marks Act, 1999
Under this Act, brands of any distinctive character that are capable of distinguishing some goods or services of a manufacturer from another shall not be registered. Similarly, a brand mark shall not be registered if it deceives or confuses the public, contains any matter that hurts the religious feelings of any section of citizens, contains obscene matter or if its use is prohibited under the Emblems and Names (Prevention of Improper Use) Act, 1950 (Anonymous 2019f).
The Biological Diversity Act, 2002
Foreign biotechnology companies trying to exploit India’s traditional medical systems have to bear in mind the provisions of the Biological Diversity Act, 2002. This Act stipulates that a country which wants to use the biological resources of another country should obtain the prior consent of the latter. It prohibits the transfer of Indian genetic material to agencies outside the country w'ithout the approval of the Government of India. Biological resources include plants, animals, micro-organisms or parts thereof and their genetic material. However, the Act does not include human genetic material (Anonymous 2019g).
Under the Biological Diversity Act, a three-tier institutional mechanism operates, firstly at the apex level, then at the state levels and thirdly at local levels. The apex authority (the National Biodiversity Authority) should be contacted by all foreign nationals, organizations or associations seeking access to any of India’s biological resources. Similarly, Indian nationals will have to inform the Authority before collecting India’s biological resources. Further, Indian nationals should obtain the prior permission of the Authority to transfer the results related to research on any biological resource to foreigners. However, Indian vaidyas (ayurvedic physicians) and hakims (Unani physicians) will have free access to biological resources for use within the country. Whoever contravenes or abets the contravention of the provisions of the Act shall be punishable w'ith imprisonment for a term which may extend to five years, or with a fine which may extend to one million rupees, and where the damage caused exceeds one million rupees, such fine may be commensurate with the damage caused, or with both (Anonymous 2019g).
The main objective of the Act is to protect Indian herbal wealth from over-exploitation by Western countries. Instead of closing the doors to foreign biotechnology companies, the Government of India has come up with a profit-sharing mechanism to ensure that India benefits from the commercialization of Indian herbal wealth (Anonymous 2019g).