The Centre’s decision to strictly implement the Good Clinical Practice (GCP) will affect the traditional ayurvedic system and production of medicines in India, according to ayurvedic experts.
They say GCP is suitable for modern systems of medicine like allopathy and is not practical in the production of several traditional ayurvedic medicines. In India, ayurvedic medicines are prepared based on the Drugs and Cosmetics Act of 1945. The medicines are prepared according to the directions of 58 authentic ayurvedic titles popular in different parts of the country, like Charakasamhitha, Ashtangahridaya and Sahasrayogam. These books mention nearly 550 formulations and nearly 600 species.
Apart from the generic/classic medicines, various companies make proprietory medicines by combining generic/classic medicines, says D Ramanathan, managing director of Sitaram Ayurveda Pharmacy and Speciality Hospital and general secretary, Ayurveda Medicine Manufacturers Organisation of India.
This is the practice in India for the last 65 years and is approved by all ayurvedic practioners and experts. GCP insists pre-clinical and clinical trials for all the combination medicines, including medicines being sold for the last 50 years. There should be four phases of clinical trials before prescribing and selling the medicines. According to him, at least Rs 5 crore is required for the clinical trials of each medicine.
The proposal of the Union government insists all the parameters practiced in the research, development and production of modern medicine should be applied for traditional medicines too. Ramanathan , however, says this is not practical in a traditional style of medicine manufacturing where different types of medicinal plants, oils and combinations are used for preparing medicines.
According to him, as huge amounts must be invested to set up facilities for pre-clinical and clinical trials, ayurvedic medicines manufacturers, especially in small and medium segments, would be fully wiped out. This may also result in a sharp increase in the prices of medicines.
Citing the example of China, he says, China, the world’s largest manufacturer of traditional medicines, has introduced a separate clinical practice for the traditional style of treatment. China exports traditional medicines worth Rs 5,000 crore annually while India, which has 5,000 years of experience in Ayurveda, exports just worth Rs 500 crore.
In future, there will be several complications in treating with ayurvedic medicines as insurance cover might be restricted to GCP medicines. In India, especially in Kerala hundreds of foreign citizens come only for ayurvedic based treatment every year. A large number massage oils could not be produced and sold after the GCP is implemented, he added.