The government of Kerala will shortly start enforcing the provision 158 B of the Drugs & Cosmetics Act and rules with regard to production and marketing of proprietary and patented Ayurveda products.

As per the Act, government will grant approval to market only efficacy proven proprietary and patented drugs in order to control fake products selling under the banner of Ayurveda medicines.

While speaking at the state conference of the Ayurveda Medical Association of India (AMAI),  Dr N Vimala, the state ISM drugs controller, said government wants only efficacy proven drugs marketed in the state, so all the new proprietary and patented Ayurveda products will be subjected for clinical study and safety study to prove their efficacy and safety. Licences for marketing such drugs will be granted only after submitting the safety documents.

According to her, Kerala is the first state in the country taking steps to carry out clinical and safety studies for proprietary medicines of Ayurveda as insisted by the central Ayush department through a notification dated 10.08.2010. The notification was issued by the government after making certain amendments to the D&C Rules, 1945. Once the report of clinical trials is ready, like China, India can also export herbal products to foreign countries as medicines.

“Once the government issues the order, the drugs control department will start enforcing the act. But, there should be a guideline for it. Now the government is preparing the guidelines for enforcement. It is on the lines of the guidelines introduced by central Ayush department in March 2013”, said the DC.

Later while speaking to Pharmabiz, the drugs controller said plenty of proprietary drugs are now marketed claiming cure for various diseases. But there is no proof about their efficacy. To a question whether the existing proprietary drugs in the market will be subjected for studies, she said the central government has a plan to put all such products for a ‘post-market study’ to find out their efficacy and safety. In such studies, if any of the existing products fails, its licence will not be renewed. Government wants safety documents of all proprietary medicines sold in the state.

For conducting clinical trials, government has identified three Ayurveda colleges, the government Ayurveda Colleges at Thiruvananthapuram and  Thrippunithura and VPSV Ayurveda College at Kottakkal. The toxicity and safety study will be carried out at the Ayush cluster, Care-Keralam in Thrissur.

There are about 890 ISM manufacturing units in the state and about 3000 proprietary medicines are marketed from these companies, said the DC.