The enforcement of the mandatory good manufacturing practices (GMP) among the Ayurvedic drug manufacturing units under Schedule T of the Drugs& Cosmetics Act has become an idealistic exercise with no clear direction. Despite the expiry of the thrice extended deadline for the industry compliance with GMP two months ago on January 1, 2003, majority of the units across the country are yet to comply with it as Department of ISM and State enforcement authorities blame each other on the implementation part.
While the state drug control authorities are of the view that the certain rules are yet to be made in a more pragmatic way, the Department of ISM blames the State DCs for not enforcing the law appropriately. However, even the recent revision incorporated and notified by the Central Department is not made any clarity on the compliance of the rules by the existing units as far as the deadline and certain other provisions. The Department has notified the revised Schedule T in March this year, which was supposed to make certain changes in the earlier rules in accordance with the suggestions from the industry as well as the state enforcement agencies.
The industry sources, however, alleged that the revised Schedule T does not have any significant alterations from the earlier one except the changes in the mandatory requirement of appointing qualified people in the quality control section permanently. As per the fresh guideline, the requirement of appointing three qualified people (one BAMS graduate and two science graduates) in the QC on permanent basis has been diluted by allowing two posts (graduates in Chemistry and Botany) on temporary basis. However, the requirement of having another BAMS graduate in the production department remains as it is, despite the industry suggestion to be flexible on the same.
Dr DRamanathan, general secretary, Ayurvedic Medicine Manufacturers of India, says that for the tiny units, it will become too impractical to afford two qualified doctors in their unit and moreover insisting the appointment of a qualified doctor in the production department is not essential as well in practical sense.
However, Dr S K Sharma, Advisor, Department of ISM, said that the Department has made the final revisions by taking all aspects into consideration. So there is no question of being more flexible on the GMP regulations. "The implementation of the Law is the duty of the state and they have been given discretionary powers as well to be flexible in certain rules in case of tiny units. Thereby, it is their failure reflects in the noncompliance of majority units with GMP," he said.
He informed that many of the state authorities are yet to report to the Centre about the GMP compliance position in the respective states and also the number of tiny units to utilize the financial schemes announced by the Centre to comply with the GMP.
However, the drug control officials from various states maintained that they are still not in a position to initiate the implementation and also to action against the units those are not complied with the Schedule T requirements, as there is no clear direction from the Centre in this regard.