Mumbai: Acting on alerts from several importer nations on the poor quality of India’s traditional medicines, which has hit exports over the years, the Union government wants to set up an entity to ensure quality benchmarks.
The government proposes to establish an export inspection agency to ensure traditional drugs meet official quality standards, according to a draft notification seen by Mint.
The move, first of its kind in India, could completely change the way traditional medicines are exported from the country.
The sector, which exports products worth Rs300 crore mainly to the US and Europe, currently requires no quality approvals, unlike allopathic medicines.
Although modern drugs have to pass stringent quality checks by regulators of importing countries by way of inspection at manufacturing facilities and other mandatory tests, these were not applied on Ayurvedic and allied products because these are sold mostly as non-drug items in international markets.
The proposed agency will be vested with powers to ban the export of any medicine that does not conform to government yardsticks, or does not have an inspection certificate.
An exporter can obtain a quality certificate from the agency after submitting data related to manufacturing, materials used and other regulatory standards, along with a fee that would range between Rs5,000 and Rs50,000 per consignment based on different levels of certification, the notification says.
A 2004 report published by the Journal of the American Medical Association pointed at heavy metal toxicity in certain Ayurvedic and herbal products from India, leading to health alerts in the US and several European countries.
Exports from firms that include Dabur India Ltd, Himalaya Drug Co. and Zandu Pharmaceuticals Ltd have been seriously hit as a result.
Although India has introduced manufacturing standards for traditional medicines under schedule T of its Drugs and Cosmetics Act, it does not regulate exports. Schedule T of the Act deals with good manufacturing practices for Ayurvedic, siddha and Unani medicines.
The Export Inspection Council of India, an agency under the ministry of commerce and industry, had circulated on 23 April the draft notification among government departments dealing with Indian traditional medicines, industry bodies, and the drug export promotion council. Suggestions and objects to the proposal have to be submitted within a month of issue.
Although leading players in the segment welcome the move, the Ayurvedic Drugs Manufacturers Association (Adma), an industry body mainly representing small and medium-sized drug makers, said the proposal will not help much in its current form as genuine manufacturers, which already follow quality manufacturing norms, will end up spending more time and money obtaining certificates.
“We are in the process of preparing a set of changes that will address these issues in the proposal. It will be submitted to the Export Inspection Council soon,” said Adma general secretary Ranjit Puranik, who is also managing director of Mumbai-based Ayurvedic drug maker Shree Dhootapapeshwar Ltd.
The new proposal will make some difference in the overall perspective about Indian traditional medicines in overseas markets, said an industry expert working at a leading multinational company producing herbal products. The expert did not want to be named as he is not authorized to talk to the media. Although India has been exporting traditional medicines for several decades, it is yet to make a dent in global markets for these products.