With barely eight alternative medicine manufacturers having opted for Ayush ministry’s “AYUSH Premium Mark” certification scheme so far, the ministry is worried about the smooth export of Ayurvedic medicines. The ministry has appealed to the drug manufacturers to get ‘good quality’ tag for easy export of their medicines.
Ayush Ministry has introduced voluntary quality certification systems in accordance with World Health Organisation (WHO) Good Manufacturing Practices (GMP) guidelines and Quality Council of India (QCI) scheme of Ayush Premium Mark due to emerging trade and export opportunities for Ayurvedic medicines.
However, the GMP is mandatory for manufacturing Ayurvedic medicines within India and the Ayush Premium Mark for export is still voluntary. “Only eight firms have sought the Ayush Premium Mark so far. Ayurvedic drugs are badly regulated within India but for export purposes, it is very important to take Ayush Premium Mark for authentication,” said Anil Kumar Ganeriwala, Joint Secretary, Ministry of Ayush.
“Gradually all the manufacturers who export their drugs will come forward to get the ‘good quality’ certification for lucrative business as it helps in export and easily enter the international pharmaceutical market,” he said. Modernisation of Ayurvedic Drugs Manufacturing Process Drugs & Cosmetics Rules 1945 have provisions for manufacturing of Ayurvedic drugs under license in accordance with the quality standards prescribed in Ayurvedic Pharmacopoeia and Good Manufacturing Practices.
EVIDENCE OF SAFETY REQUIRED
“Evidence of safety and effectiveness is required for obtaining license to manufacture Ayurvedic medicines and shelf-life or date of expiry of various dosage forms has been prescribed in Drugs & Cosmetics Rules, 1945. Augmentation of pharmacopoeial standards has also been taken up for improving the quality of Ayurvedic medicines,” Shripad Yesso Naik, Minister of State (Independent Charge) for AYUSH, told Rajya Sabha on Tuesday.
The Indian Council of Medical Research (ICMR) said that clinical trials should be made mandatory for all the alternative medicines to ensure safety. A recent study done by pharmacology department of All India Institute of Medical Sciences (AIIMS) attempted to evaluate heavy metals contents in Ayurvedic drugs on over 78 formulations.
It found that heavy metals in all metal formulations were above the WHO limit. In herbal formulations, lead in 19.6 per cent, cadmium in 21.4 per cent, mercury and arsenic in 5.3 per cent were found to be above the limit.It was found that Lead in 52.6 per cent of samples, cadmium in 26.3 per cent and mercury and arsenic contained in one herbometallic sample was above the limit.