Salon, Himachal Pradesh;The Ayurveda Department has exempted manufacturers from following the rigours of seeking product approval by the technical committee for the same formulation having a different trademark.
As per January 28 order, a firm will have to procure an NOC in the shape of an affidavit from the manufacturer who had the formulation approval. No change will, however, be allowed in the formulation by way of composition, indications, manufacturing process, specifications, etc indicated the order.
The decision will also allow the manufacturers to shift any formulation from one unit to another without seeking the approval from technical committee by submitting an affidavit from the original licence holder.
Director, Ayurveda, Sanjeev Bhatnagar, said the technical committee was supposed to evaluate new products and when a formulation had been examined, there was no point in re-examining it and making the process tedious. This decision would provide speedier clearances to the industry.
The move comes on a representation made by a Baddi-based manufacturer Indian Herbal Remedies, who had been exempted from the process which would also apply to the industry, said Gaurav Verma, Chief Administrative Officer of the unit.
Terming the decision historic, Verma said, “We can secure speedier approvals as was permissible in the pharmaceutical industry where we give a reference salt and get approval under a new trademark.”
Manufacturers could keep the same batch for many formulations and maintain same BPRs for different products with different brand names. This can also help them in specialising in one type of formulation and facilitate quality product manufacturing for the third party.
This will help new entreprenuers in easing their manufacturing processes and reducing raw material inventory costs.
The department has also done away with the quota of five products per meeting per manufacturer and in lieu unlimited products per meeting will be approved if found in order.
For more :- https://www.tribuneindia.com/news/himachal/ayurveda-drug-makers-given-major-relief/724154.html