Are you skeptical about consuming ayurvedic and unani drugs? Get ready for a double dose of assurance about the quality of manufacturing, efficacy and side-effects.
Discarding the process of easy grant of licences, companies should get ready to answer tough questions while applying for approvals for drugs. Apart from the already existing patent regime, the government is set to form a new body to screen and clear applications for the proprietary drugs filed by ayurvedic, siddhi and unani drug makers, including Himalaya, Dabur, Patanjali, Zandu and Hamdard.
India is considered to have a long and great tradition of saints and hermits who evolved their own indigenous systems of healthcare, such ayurveda, yoga and siddha, and is the land of genesis of such medicines. Ayurveda offers affordable solutions to these non-communicable diseases, lifestyle-related diseases, such as hypertension, diabetes, and cancers, have become the greatest health challenges.
“We are in process of forming a central technical advisory commission (CTAC) to screen and approve new patents. After getting the clearance from the commission, the company will apply for licence to manufacture and sell from the concerned state licensing authority or may apply for the grant of patents,” Ajit M Sharan, secretary, Ministry of Ayush (ayurveda, yoga, unani, siddha and homeopath), told HT.
Companies currently only apply for licences by submitting the papers on clinical trials and efficacy evidences to state licensing authorities. In case of innovation they approach the patent office directly, but applying for patent is voluntary. “Many small companies have been introducing new formulations without proper scientific studies, which had led to unethical practices and promotions involving cheap gimmicks. This will also help ensure that the number of fancy applications will come down and only the serious applications will be processed,” said J L N Sastry, R&D head (Ayurveda) at Dabur India, which has filed 14 patent applications in the last four years.
The government also has similar concerns.
“It is easy for companies to just apply for state licence. However, the objective of introducing a new body is to pass drugs with unique discovery to boost innovation in the industry. We want to assure consumer about the quality and efficacy of ayurvedic and unani medicines. The procedure to manufacture and sell these medicines is lenient today. But companies should get ready for tough questions ahead,” pointed Sharan.
According to estimates, more than 600 drugs come for licence approvals every year. The number is growing by 25% year-on-year.
Prime Minister Narendra Modi has also announced several initiatives to promote ayurveda. “Creating a vertical structure for AYUSH drugs in the Central Drug Standards Control Organisation, control over misleading advertisements and extension of financial support to the states under National AYUSH Mission for quality control activities are important initiatives that are underway,” Prime Minister Narendra Modi had said at the Global Ayurveda Festival in Kozhikode in February.
The ministry plans to device steps for approvals of patent applications based on two segments – low risk and high-risk drugs. “The drugs that have higher metal and mineral ingredients would fall into the high-risk category and companies would be pushed to file more details on research and evidences,” Sharan added.
“Applying for patents is a cumbersome process so manufacturers try and skip it and prefer going to the state authority for manufacturing and marketing licence,” said an official in the patent office.
After the entry of Baba Ramdev’s Patanjali, the market is gearing up for tough competition. While Hamdard plans to launch about 10 new products across categories this year, another popular herbal brand, Dabur, is reviving its old ayurveda brand Ayush. Multinational FMCG firm Hindustan Unilever has also brought back its ayurveda brand, Lever Ayush.