1. What permissions are required to manufacture and sell Ayurvedic Siddha Unani medicines?
A pharmaceutical manufacturing license is the basic requirement for manufacturing Ayurvedic Siddha medicines for sale in India.

2. What is GMP? Certificate?
A GMP certificate is a certificate granted by the Drugs Control Department to establishments that maintain infrastructure and operations as prescribed by Schedule T of the Drugs & Cosmetic Act, 1940 and Rules, 1945, so that it can be said to be a clean manufacturing process.

3. What are the basic preparations to get the license?
Infrastructure and arrangements as per schedule T of Drugs & Cosmetic Act 1940 & Rules 1945

Building

A. A minimum 1200 square feet building with washable walls and floors and arranged to be insect proof.
B. Machine tools and utensils required for the manufacturing process of the drugs intended to be manufactured.
C. Availability of electricity and clean water.
D. Rooms for sorting and storing the marketed drugs as required for the manufacturing process
E. Rooms for keeping various tests required for manufacturing packing process
F. Machinery rooms
G. Lab for quality testing of medicines
H. Special facilities for bottling and packing of medicines
I. Stock room for packed medicines.
J. Rest rooms and toilets for employees
K. Proper waste management for the disposal of solid and liquid materials

Employees

1. Technical category qualified by degree (BAMS,BSMS, BUMS) for pharmaceutical manufacturing supervision.

2. In the quality control department

A. Chemist – B.Sc Chemistry/BPharm/BPharm (Ayurveda)
B. Botanist – B.Sc Botany/BPharm (Ayurveda)

4. Where to apply for drug license?
The application should be prepared with sufficient documents and submitted to the zonal offices having jurisdiction over the respective districts

5. Where are the regional offices located?

Office of the Inspector of Drugs (Ayurveda), Kollam- (for Kollam, Pathanamthitta and Kottayam Districts)

Office of the Inspector of Drugs (Ayurveda), Ernakulam – (For Alappuzha, Ernakulam, Thrissur, Palakkad and Idukki Districts)

Office of the Inspector of Drugs (Ayurveda), Kozhikode (for Kozhikode, Malappuram, Wayanad, Kannur, Kozhikode Districts)

6. Do Ayurvedic Siddha Unani medicines need to be licensed for sale?
Ayurvedic Siddha Unani medicines do not require a special license to be sold. It is important to note that Ayurveda Siddha Unani medicine sales should only sell medicines manufactured under an approved Ayurvedic medicine manufacturing license.