Health Minister Ambumani Ramdoss Wednesday confirmed that the samples of Ayurvedic formulations provided to the government by Communist Party of India-Marxist leader Brinda Karat did carry "traces of human and animal remains", adding, the examination reports have been sent to the Uttaranchal government for proper investigation and further action.
Talking to reporters in New Delhi, Ramdoss said the two samples of Divya Pharmacy given by Karat were sent to various laboratories for their chemical analysis and DNA finger-printing and the report has confirmed that the samples did contain DNA of human species. Another sample contained dried tissue of animal origin, he said.
He said the matter has been referred to the Uttaranchal drug controller and if after proper investigation, Swami Ramdev was found to be guilty, action would be taken against him under the Drug and Cosmetics Act, which could include cancellation of license to manufacture the drug and even imprisonment of up to two years.
Ramdoss said there were issues concerning the labelling of the samples and the question of adulteration also.
However, the health minister acknowledged that the government had not collected samples of the drugs and it had merely got the samples given by Karat tested.
Admitted that it was the first time that the samples provided by an individual had been tested by the government, he said the government took action on Karat's request as she is an member of Parliament.
"We have referred the matter to the drug controller of Uttaranchal stating that as per the test reports, prima facie there is some violation. It is for the authorised agency to conduct the inquiry and take action if the allegations are found to be true. If necessary, it can also collect fresh samples from the so called ashram," Ramdoss said.
This is being considered significant in view of the controversy over the name of the pharmacy. Apparently, the samples provided by Karat had the label of Divya Pharmacy while the Uttaranchal government has said there was no pharmacy in this name. Instead there was one 'Divya Yoga Pharmacy'.
The samples given by Karat were sent by the Central Council for Research in Ayurveda and Siddha to various labs including the National Centre for Characterisation and Composition of Material, Hyderabad, Centre for Cellular and Molecular Biology, Hyderabad, Department of Vetenary Pathology at Madras Vetenary College, Chennai and University of Animal and fisheries, Kolkata.
Admitting that proper testing and labelling of various formulations being manufactured under the Indian system of medicine were not being done by some manufacturers, Ramadoss said the government was taking many a measure for streamlining the system and ensuring proper labelling and good manufacturing practices.
"We are testing about 35,000 samples of both Indian system of medicine and allopathic -- every year and are planning to increase it to 100,000 samples. A national drug authority is being set up. A World Bank funded capacity building project is being undertaken for modernising the laboratories and training of experts," he said adding, streamlining the entire procedure would take about two to three years.
According to the minister, norms have been laid down and manufacturers have to certify that their herbal products do not contain heavy metals or any other harmful ingredients. The manufacturers confirming to GMP are given subsidy and they have to self-certify. If they are found to be violating the legal requirement, they have to pay for it, their licenses would be cancelled. They would be fined and even imprisoned.
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