Ayush exports from Karnataka grind to a halt

Exports of several Ayurvedic products from Karnataka have been hit and launch of new products has delayed as the drug-licensing authority is not functioning.

The position of the Drug Licensing Authority in the Ayush Department has been vacant for two months now after the government removed the previous official following an internal report.

The authority plays the crucial role of issuing licences for new products, documents related to exports and tenders and so on. But with the post yet to be filled, this process has come to a standstill.

Karnataka has hundreds of Ayush companies, including 240 that make Ayurvedic products. On average, about 30 new products come up for licensing in a month. A Bengaluru-based Ayush company said it was suffering huge losses because it had to stop exporting some products.

“Countries that import our products require the re-registration of products annually, or in some cases, every three years. For this, we need to submit dossiers, including the Free Sale Certificate and a Certificate of Pharmaceutical Product (COPP), both of which should come through the Ayush Department,” said a senior executive of the company.

The company exports nearly 100 products, some of which were due for re-registration recently. “We have faced losses. The government also suffered losses in tax revenue,” the executive said.

Other documentation needed for export, such as companies’ renewed manufacturing licences, has also been delayed, he said.

The introduction of new products into the market has also been affected, said Ramdas D Raikar, honorary president of the Karnataka Ayush Drugs Manufacturers’ Association.

The company official quoted above said “licensing applications for 30 new products come to the authority every month”.

“This means the market launch of about 60 products has been delayed, which is a loss for companies,” he said. “Some products are also launched during certain seasons — for example, cough medicines during winter. If they can’t be launched in winter, they must be moved to the next suitable season.”

An executive at another large Ayurvedic company said they were not affected because many of their products need licensing from FSSAI rather than the Ayush department.

“But other companies that rely heavily on government tenders would be affected because they need certificates like market standing and performance certificates from the department to bid for tenders.”

After receiving complaints from manufacturers, the association wrote to Principal Secretary (Health) T K Anil Kumar on January 12, requesting him to renotify the Drug Licensing Authority, as all licensing matters including critical clearances had come to a standstill. A Deputy Drug Controller of the Ayush department usually holds the position.

Kumar said the Deputy Drug Controller, who previously occupied the position of the Drug Licensing Authority, was removed based on an internal report.

“According to the report, he should not be given any executive post. After this, we considered two other officers for the post but they did not have enough seniority. We hope to find a suitable person within a week,” he said.