CTMR -TASUDMA workshop

Centre for Traditional Medicine & Research and Tamil Nadu Ayurvedic, Siddha, Unani Drug Manufacturers Association organized a workshop at Hotel Palmgrove, Chennai on 26th Feb 2011 on ‘Technical obstacles in ISM drug manufacturing and Testing’ to educate its members about WHO Guidelines and Ayush Protocols issued by the Department of Ayush provided a valuable forum for exchange of views and to design practical ideas on issues faced by the ISM sector.Most of the participants including Vijay A Mehtha, president of TASUDMA, highlighted the grave issue with regard to non-availability of raw drugs. Mehtha said government should intervene into the raw drug crisis faced by the manufacturers otherwise the ISM industry in the country will suffer a lot. Most of the drugs producing companies are struggling for want of raw materials for the preparation of medicines which are getting popular in many countries.He said there are more than 6000 Siddha and Ayurveda outlets in Tamil Nadu and a host of people in various capacities are getting jobs in the manufacturing companies and in hospitals. Vijay Mehtha appealed to the government of Tamil Nadu to immediately intervene in the problems of ISM manufacturers of the state complaining that currently there is no basic ground for the industry to grow. Measure should be taken to avail sufficient quantity of raw drugs to the big and small companies, he demanded.Dr T. AnandAN, director -in-charge for the Siddha Central Research Institute, Chennai said that because of lack of modern laboratories with state-of-the-art technology, it becomes difficult to ensure hundred percent quality in drugs. There are many drugs being imported, but it is difficult to find out their botanical identity. So it is impossible to set standard of certain drugs. According to him, even the pharmacopoeia committee is facing troubles in identifying single drugs. Identity, purity and strength of the drug are standardized and published in the monograph by the Siddha pharmacopoeia committee.He further said Tamil Nadu is blessed with large quantity of flora and fauna which are used for the formulation of Siddha medicines, but it is not sufficient for the total requirement of the state.While speaking on ‘Gray areas in ISM pharmacopoeia and use of correct raw materials’, Dr Usman A Ali, director of CTMR, said farmers should be encouraged to cultivate herbs. He spoke on various types of herbs and how they were used by the traditional healers in olden days and how they are used now by the physicians today without acquiring thorough knowledge about the plants.Dr T Thirunarayanan, secretary of Centre for Traditional Medicines and Research, while speaking on WHO Guidelines and Ayush Protocols for Drug Regulations’ said that the guidelines issued by the Department of Ayush, will definitely improve not only quality of the products but also improve higher sales for the manufacturers . Quality products are the key for the ISM systems popularization both within the country and overseas. He mentioned there is no specific mention about the list of laboratories where the drugs can be tested for toxicology and efficacy studies. He said Tamil Nadu has five approved laboratories, out of which three are in Chennai, for testing the products. Universities like SRMC, Shastra, TNUVAS do have toxicology labs. But the small scale units cannot afford the expenses to be incurred to access the facilities in the approved labs. So the department should come into an agreement with the universities and institutes by signing some MoUs for the sake of small scale manufacturers.Dr Helmut Weidlich, Professor of Dr George Kurz GMBH Institute in Germany, in his speech on ‘Registration in European Union countries’ said import of medicine into European countries are approved through the national authorities for medicine. The authorities there check who distributes the medicine to their consumers. He said in the western countries, to get some medicine from a pharmacy, one has to get medical advice from the authorities.The workshop has led to a greater understanding of many of the issues involved in the manufacture, sale and export of Indian drugs and much progress has been made in the development of concepts and procedures suitable for complying with the norms of Ayush protocols.Besides senior officers from regulatory side, the workshop was attended by 40 participants from different parts of the state.

CTMR appointed GMP consultant for IMPCOPS

The six decades old multi-state cooperative society, Indian Medical Practitioners Cooperative Pharmacy and Stores Ltd (IMPCOPS) based in Chennai has revived its GMP status after a period of two years. IMPCOPS, the only one ISM practitioners’ society in the co-operative sector in the country had lost its Good Manufacturing Practice (GMP) certification in 2007 because of lack of infrastructural facilities and lack of continuous upgradation.Recently, the director board of the society has decided to increase its sales to Rs 35 crore in the next few years from its present turnover of Rs 17 crore. Following the decision, the board has approached the Chennai-based ISM service provider, Centre for Traditional Medicine and Research (CTMR) to suggest measures for achieving the lost GMP status. CTMR, after carrying out a detailed audit in the unit, recommended some proposals for reviving the earlier status. Along with this, IMPCOPS has prepared a project report to upgrade the lab and the manufacturing facilities to increase productivity and turnover. On submission of the report to the ISM directorate, inspections and testing of finished product samples were carried out by the concerned authorities in October this year, and finally the State Licensing Authority of ISM, Dr Sarojini Devi, has issued the long awaited Certificate to the society. The society has further appointed Vaidya. S Usman Ali and Dr T Thirunarayanan of CTMR as consultants to carry out the project.The upgradation envisages environmental friendly green energy, fuel efficient systems, alternate power source to overcome frequent power cuts, R.O plant etc. The Lab will develop Standard Manufacturing Procedures for herbo-mineral preparations which would be a model for other industries in the sector.The doctors-cum-manufacturers’ society has been manufacturing 700 formulations of Ayurveda,Siddha and Unani generic formulations and was the first ISM manufacturing facility in the country to mechanize its operational methods. The society claims that it has a live membership of 10,000 practitioners and possesses a good brand image for its products which are being produced without any deviation from the way the classical texts have illustrated and maintain good quality standards. However, the society has been encountering some kind of problems in supplying its products to various government institutions in Tamil Nadu and neighbouring states due to non-renewal of GMP certification two years ago.According to sources, the society was struggling hard to upgrade its facilities as it has a huge manpower cost, besides a host of expenses including the maintenance of old equipment, increasing energy cost and processing of water. The delay in upgrading the facilities was the reason for losing the GMP status, said the consultant Dr T Thirunarayanan.Dr M K Thyagarajan, secretary of the society said that this initiative will help the company to fulfil institutional orders from government of India and other state governments and help increase its turnover. He said the workshop on GMP implementation conducted by CTMR last month was an eye opener to the different shop floor manufacturing supervisors and staffers who have assured to maintain the GMP status always. Impcops proposes to submit the project report to the Department of Ayush for assistance under Centre for Excellence Scheme. The joint secretary of Department of Ayush, B Anand during his recent visit to the company assured to consider the proposal as it is an old surviving cooperative and a pioneer in manufacturing ISM drugs.