The arrangement will help companies cut cost since separate facilities are not required for manufacturing products licensed by the Food Safety and Standards Authority of India (FSSAI) and ASU products, an industry expert told us.
India’s Ministry of AYUSH (Ayurveda, Unani, Siddha, and Homoeopathy) which regulates the use of traditional Indian medicines made the announcement on August 31 upon receiving industry feedback.
In actual fact, there is no rule prohibiting companies from making FSSAI and ASU products in the same facility.
“In this regard, it is to state that there is no specific prohibition to use combined setup of manufacturing line and equipment for manufacturing products licensed under Ayurveda, Siddha, and Unani, and FSSAI in Drugs and Cosmetics Act 1940 and Rules made there under.
“Furthermore, there is no direction issued by the FSSAI for restricting the manufacturing of food products under FSSAI License / Registration at premises where AYUSH products are being manufactured,” said the Ministry of AYUSH.
Speaking to NutraIngredients-Asia, Pradip Chakraborty, former director at FSSAI, said that the announcement from AYUSH was not pertaining to new rules but a clarification on existing rules.
This is because drug manufacturers are not allowed to use their facility to manufacture any other products and the rule is thought to be applicable to facilities manufacturing other types of products, including the FSSAI and AYUSH-licensed products.
The industry has been confused for years, Chakraborty said.
“As a matter of fact, some of the manufacturers who make FSSAI licensed products are confused as to whether they could use the same facility to manufacturer AYUSH products as well.
“This is because as per Drugs Controller General of India (DCGI) guidelines, drug manufacturers are not allowed to use the same facility for manufacturing any products other than drugs. Drug manufacturers who make FSSAI-licensed products build separate facilities to manufacture those products,” he said.
As such, the practice all along is that companies build separate facilities for making FSSAI or AYUSH products. However, it is mostly the bigger companies that have the capital to build separate facilities.
The average cost of setting up a manufacturing facility in India is about 100 crores (US$120m), he said.
Thus, the clarification will not only help firms cut cost, it will also enable smaller companies to manufacture both AYUSH and FSSAI products.
Across the country, AYUSH products are seeing a revival due to its efficacy and absence of side effects, he said.
He added that the authorities made the announcement upon receiving a request for clarification from Sarvottam Health Care – a OEM manufacturer that he was providing advisory services for.
However, companies should take the necessary precaution to avoid cross contamination when making FSSAI and AYUSH products in the same facility.
“ASU facilities can be utilised for manufacturing food products licensed under FSSAI, provided that the manufacturing company should have due precautions to avoid cross contamination as per Schedule T of Drugs and Cosmetics Act 1940,” the ministry said.