The department of Ayush’s good clinical practice (GCP) guidelines has fallen short of industry expectations. The final gazette documented is seen to be brimming with faults and urgently needs clarification of details. Though industry experts and academicians were consulted, yet the government has failed to put in their valuable inputs, pointed out representatives across the industry.
According to DBA Narayana, leading scientist, “While the intention of the Ayush department to bring out a formal guideline is appreciated keeping away the science of trial designs and focus on ethics committee, informed consent and other aspects of products and documentation, the final notified format is a hotchpotch presentation. There are slip-ups in the final version which is creating considerable apprehension and confusion. Over 90 per cent of the Ayush units engaged in the production of Ayurveda, Unani, Siddha and Homoeopathy drugs, are small and medium units. Now this 114 page guideline is seen as a tough document to comprehend by them.”
“The contents have failed to sustain the actual essence of the guidelines and there is also an absence of legal clarity. Further, in the section on new proprietary medicines, which recognises alcohol+water preparations, details of data submission and pilot human studies, we see no connection between the guidelines and the annexure. This leaves a huge ambiguity and could be misused by the regulatory authority and may end up harassing the industry. There is no mention whether MBBS or BAMS doctors would conduct the human studies or who would head the Ethics Committee,” said Dr Narayana.
Voicing similar concerns, JSD Pani, president, Karnataka Indian Medicine Manufacturers Association (KIMMA) stated that “despite industry consultation the inputs put forward by experts were not considered. It is a copy-paste of the allopathy GCP norms. Ancient system of traditional medicine needs to be relevant to modern concepts. The current guidelines, are seen as a challenge to conduct clinical trials based on modern medicine systems”.
“There are apprehensions on how the Ayush industry could adhere to GCP guidelines. For instance, government had indicated that only 56 per cent of the 9,000 Ayurveda units have adhered to the Schedule T GMP norms, enforced a decade ago. In such a scenario GCP adherence would be difficult for the small-medium manufacturers. But, what could come in as a support is the Ayush Clusters model that has been commissioned in Kerala and Punjab and to be flagged off in Karnataka in a few months. The tiny small and medium industries located in the Cluster could be guided by experts for GCP adherence,” pointed out Pani.
In order to ensure total compliance, government should interact with industry, academia and researchers and the state regulatory officials. “Frequent, intensive workshops and training programmes are needed to educate the industry about the new norms and help remove the fears on its implementation. Regulators too need to attend so that they can appreciate the issues and work positively to help industry comply with the guidelines. It is a known fact that most Ayush regulators do lack experience in clinical trials unlike their counterparts in the DCGI office,” said Dr Narayana.
Appreciating the guideline as the an important document for the Ayush sector after the Schedule T norms, Dr Nagesh Sandu, Chairman, technical sub-committee, Ayurvedic Drug Manufacturers Association (ADMA) and director, Sandu Brothers (P) Ltd. stated that although the norms for clinical research are broad-based they are not specific to many aspects of human studies. “We need to see how this would be implemented in the wake of capacity gaps. The government will need to interact closely with the industry to ensure compliance to the norms.”