The department of ISM had drafted the GMP guidelines to be included under the Schedule T of the Drugs and Cosmetics Act more than two years ago. These guidelines were notified and become mandatory toward the end of 2000. The government had given 2 years time for the units to implement these norms considering the fact that a large majority of these units are small and tiny. The objective of the whole exercise was to upgrade and bring uniformity in the manufacturing standards of thousands of small and tiny ayurvedic units spread across the country. Barring 20 or more large units, most of these ayurvedic units in India do not have adequate space, cleanliness and hygiene in their operational areas. The government initiative to bring in some minimum standards in manufacturing practices has to be welcomed in the context of the growth potential of this sector. There has been a substantial spurt in demand for various ayurvedic preparations within the country and also from developed countries in recent years. A range of 600 ayurveda formulations is being currently exported to the US, Europe and other developed markets. The estimated value of the annual export of ayurvedic products is placed at Rs 350 crore.

A crucial factor that will determine the future growth of ayurvedic industry in India is exports although the domestic market is also growing. The importing countries are increasingly demanding authentic documentation of ayurvedic products in terms of its ingredients, therapeutic values and scientific data. This is now becoming a major hurdle for exporters of these products as medical control agencies in importing countries are getting assertive about such documentation. In short, ayurvedic units have no choice but to adopt the mandatory GMP in their manufacturing facilities, sooner or later, if they have to remain in business. Now even after more than 2 years of the notification, a large percentage of ayurvedic units are yet to adopt the GMP guidelines. This is despite the fact that some key dilution of the norms have been incorporated as per the suggestions made by the industry and some state drug control authorities. The department of ISM has done its job by providing a detailed set of guidelines with some modifications. It also has allocated some funds for helping small and tiny units to upgrade the manufacturing facilities. Now the ball is in the court of state drug authorities. It is they who have to act if the implementation has to take place nationwide. Surprisingly, the state drug authorities in most states are still hesitating to implement the norms even long after the expiry of the last deadline. This is not an acceptable stand.