Speaking at the inauguration of the buildings of Homoeopathic Pharmacopoeia Laboratory (HPL) and Pharmacopoeial Laboratory for Indian Medicine (PLIM) and PLIM’s workshop on WHO Guidelines for GMP of Ayurveda, Siddha and Unani (ASU) Drugs and laying of Foundation Stone of PLIM Guest House at PLIM Campus today, the Union Minister for Health & Family Welfare, Dr. Anbumani Ramadoss said that the huge potential of our traditional systems is proven and hence there is no question why we cannot produce world class natural medicines. The Minister of State for Health & Family Welfare, Smt. Panabaka Lakshmi, Secretary (AYUSH), Smt. Anita Das, Dr. Salim Habayab, WHO Representative to India, Dr. D.R. Lohar, Director, PLIM and other officials from the Ministry and PLIM were present at the function.
The following is the summary of the Health Minister’s speech:
Quality control & standardization of ASU drugs has been the thrust area right from the day when these drugs were brought under the purview of Drugs & Cosmetics Act. Government have taken many initiatives from time to time to strengthen the drug standardization and quality analysis system and PLIM is known to have played a pivotal role in all these outcomes & achievements, which we can boast of in the area of development of drug standards.
Today when we look back to the history of PLIM’s existence and its infrastructure, it looks surprising how the sophisticated work of pharmacopoeia was done with moderate infrastructure and manpower. It is only after the establishment of Department of AYUSH in the Ministry of Health & Family Welfare in 1995, when focused attention was given to strengthen the laboratories and notify it as appellate laboratory for testing of ASU medicines and raw materials.
Constant Governmental support has brought the PLIM to a stage wherefrom we now expect that quality standards of Ayurveda, Siddha and Unani products are evolved as per global requirements and companies following those standards could be able to get their products registered for market authorization in foreign countries. More responsible and dedicated role is expected from PLIM to deliver need-based things in time-bound manner and in accordance with the emerging national and global needs and help the State Drug Controllers in training their staff and capacity building.
The phenomenal development of AYUSH systems during the last 30-40 years has now gained momentum. The scope & opportunities of growth and R&D are expanding vertically as well as horizontally and the systems are poised to disseminate globally. AYUSH products, particularly Pancyurveda and Yoga in particular are increasingly becoming popular nationally and internationally.
I understand that despite tangible achievements in the field of quality control and standardization of drugs like notification of Good Manufacturing Practices (GMP) and pharmacopoeial standards of ASU drugs under the Drugs & Cosmetics Act 1940 and the Rules thereunder, there is a lot yet to be done. Questions encountered on safety-efficacy of AYUSH are a matter of concern, which need to be addressed by elucidating authentic manufacturing procedures as described in the classical texts. As a result of growing demand of medicines of Ayurveda, Siddha, Unani and Homoeopathy both for domestic consumption and export, the problem of supply and availability of sufficient quantity and quality raw materials needs to be addressed.
You know that China is the leader in the export of traditional medicines and has an export of more than US $10 billion per year and it is growing annually at the rate of 23-25%. As compared to China the India’s exports of ASU products is hardly worth Rs. 700 crores i.e. around 2% of the global market of natural products. Out of these exports, only 40% is of value added products. 60 % export is of herbal raw materials, plant parts and plant extracts. I think the main reason is lack of coordinated and focused attention.
We have to develop our products fulfilling EU/USFDA quality parameters for clinching a larger share of world market. In doing so GMP compliance from industry is important and it has to be sincere and dedicated towards enhancing exports. Otherwise the Government initiatives towards supporting industry to set up in-house quality control laboratories, development of common drug testing facilities for industry clusters of small & medium scale units will go waste.
I am happy to know that the PLIM is involved in developing and publishing pharmacopoeial standards of 518 single herbal drugs and 50 Ayurvedic compound formulations. I hope the PLIM will continue to do the scientific work with vigour and spirit since suitable working environment has been given to them and strengthening of infrastructure and manpower is being done.
I am indeed very glad to inaugurate the new buildings, the two-day Workshop on WHO-GMP Guidelines for ASU medicines and to lay the foundation stone for the PLIM Guest House. I wish the PLIM and HPL all continued success.