For establishing ayurvedic manufacturing unit or pharmacy, there is a well defined protocol for obtaining drug manufacturing license for sale of ayurvedic medicines and or cosmetics in India and for the purpose of exports. As per the rules and regulations of the Drug and Cosmetic Act, it is mandatory to obtain drug manufacturing license for sale of ayurvedic medicines and or cosmetics in India and for the purpose of exports. This is equally applicable for all the states across the country.
In Drug and Cosmetic Act, in addition to an issuance of new license, there is a provision of renewal of license, definition regarding manufacturing and guidelines for good manufacturing practices (GMP). The process of issuance and renewal of drug manufacturing license for sale of ayurvedic medicines is done by the Licensing Authorities appointed by the State government. The same protocol is applicable for manufacture and sale of Unani Medicines.
GMP and ayurvedic drug production
As per description of quality control parameters of the good manufacturing practices, Quality control section will have a minimum of one person with Ayurveda/Unani/Siddha qualification recognized under Schedule II of Indian Medicine Central Council Act, 1970. Two other persons, one each with a Bachelor qualification in Botany/Chemistry/Pharmacy could be on part-time or on a contractual basis.
Technical persons for ayur drug mfg
The majority of the pharmacies hires person with Ayurvedachraya (B.A.M.S) qualification for the purpose of the technical work. Some rare ayurvedic manufacturing unit or pharmacies may employ a person with qualifications in Ayurvedic pharmacy {B. Pharm - Ayurveda} in the absence of a person with Ayurvedachraya qualification. Well established ayurvedic manufacturing unit or pharmacies may hire persons with additional or higher qualifications like M.D. (Ayurveda)-Dravyaguna or Rasa Shastra.
Process of hiring technical persons
The technical persons are either hired by giving advertisement in the news paper or commercial magazines dealing with ayurvedic or herbal or pharmaceutical business. Some companies hire technical persons by campus placement from State or private Ayurvedic Colleges. After formal interview or direct absorption, the technical person is hired on full or part-time basis.
During this process, the technical person provides copy of B.A.M.S degree and state registration certificate along with an affidavit stating that he/she is not working for any other ayurvedic pharmaceutical company or pharmacy. A person submitting Central registration certificate is not entertained by the State Licensing Authorities (SLAs). Registration with the respective state is mandatory where manufacturing unit is located.
Duty of technical person
The technical person is responsible for searching, creating and manufacturing of ayurvedic blends from classical texts books or authorative books recommended by the Government of India. The blends can be powder, syrup, confection, decoction, infusion or medicated oils. The technical person applies for the formula for approval in prescribed format to the Licensing Authorities appointed by the State Government. Formulas are examined and approved by the team of experts appointed by the Licensing Authorities. In the previous years, the presence of the technical person was not mandatory in meeting with the proprietors of the ayurvedic pharmaceutical company or pharmacy. However, the presence of the technical person has been made mandatory during the approval process.
Scope for technical person
Ayurvedic business is at its peak in India. Ayurvedic e-commerce and ayurvedic retail pharmacies are the buzz words. This has increased the avenues for the technical persons in the ayurvedic drug industry. Some clinicians find this option as lucrative and a good source of additional income. In isolated instances, the technical persons get full-time employment where drug manufacturing is a continuous affair.
Other side of the story?
If the other side of the story is taken into consideration, practically there are several lacunas.
- The proprietor of the manufacturing unit gives respect to the technical person only up to the process of the license approval.
- In practice, the proprietor of the manufacturing units have been found to indulge in malpractices by using the degree of the technical person for the purpose of clinical practices. Sometimes, name and degree of the technical person are used in promotional material, thereby violating the Objectionable Advertisement Act.
- In general, ayurvedic manufacturing units or pharmacies are not disciplined and good pay masters.
- Despite promise, the proprietor of the manufacturing units do not give incentives on the net sale of the products sold in the market.
- Sometimes, the manufacturing units are found to have manufactured spurious medicines in the absence of the technical persons.
- Some manufacturing units use fake certifications to promote the product at national and international levels displaying the name of the technical person.
- Finally, steroidal and painkiller contamination of the ayurvedic or herbal products by manufacturing company can land technical person in legal issues.
ConclusionDue to lack of evidence based and scientific studies in ayurvedic pharmacy courses, the technical person is not well conversant with the core-issues. The technical person should acquire legal, regulatory, pharmacological and vigilance aspects of ayurvedic medicine and above all, should learn about rights reserved for him as a technical person of the manufacturing unit or pharmacy.
(Author is a herbal consultant, based in Mohali)