The Ayush ministry’s revised draft of the good manufacturing practices (GMP) for ASU drugs is unlikely to be welcomed by the small scale manufacturing units of the Ayush drug industry, the backbone of India’s traditional medicine landscape. This is because the revision corresponding to the amendment of Drugs & Cosmetics Act will become a bottleneck to the growth of entrepreneurship in the small scale sector.
 
Except a few major players, most in the Ayush drug sector are small scale units which will face more trouble if the revised draft is implemented as it is, industry sources say. The ministry has issued the draft for discussion and comments by all stakeholders, and soon it will become part of the D&C Act once the amendment is in force.
 
However, under IMCC Act 1970, registered vaidyas, siddhas and hakeems who prepare medicines on their own to dispense to their patients and not for selling, such drugs in the market are exempted from the purview of GMP, as per the draft.
 
Commenting on the revision, manufacturers of Ayurveda, Siddha and Unani drugs said the ASU drug manufacturing sector is not only supplying the largest quantity of traditional drugs, but also providing jobs to thousands of people. The revised GMP draft is not conducive to the continuance of the business. The Ayurvedic Medicine Manufacturers Organisation of India (AMMOI) is discussing the matter seriously and it will submit a report to the Ayush ministry soon, said Dr. D. Ramanathan, secretary of the organisation and the managing director of Sitaram Pharmacy in Kerala.
 
The draft mandates the licensees to evolve appropriate methodology, systems and procedures to be documented and maintained for inspection and reference. It wants that the manufacturing premises should be used exclusively for production of ASU drugs and no other manufacturing activity can be undertaken therein. Currently, many of the ASU drug manufacturing plants are used as the production facilities of allopathic medicines and vice versa. So, the revised draft should not be implemented as it is, said one manufacturer from Chennai.
 
The Ayush ministry argues that the parameters of GMP are made stricter because it wants to ensure quality and safety in each phase of the drug production and to create a situation that the manufactured drug that is released for sale is acceptable quality. Further, government wants to make it sure that the raw materials used in the manufacture of drugs are authentic, of prescribed quality and are free from contamination. All the manufacturing facilities must maintain the standards of manufacturing process and adopt quality control measures as prescribed in the draft.