The Drugs Controller General of India (DCGI) is the apex body which regulates and controls the manufacturing standards of pharmaceuticals and cosmetics in the country, through the Central Drugs Standards Control Organization (CDSCO) and the CDSCO provides the requisite licences for manufacture of various drugs and cosmetics, and acts as the Central Licencing Agency (CLA) for medical devices too, informed Shivkumar Rao, President, Vidarbha Economic Development Council (VED).
The Office of the Assistant Controller of Drugs acts as an infield office of CDSCO, which provides various manufacturing licences related to medical and pharmaceutical manufacturing units in the region. Currently the office is in Mumbai for Western Region, and all activities related to it have to be done there. Currently, importers obtain ADC clearance from Mumbai which is time-consuming and adds to the cost of imports. It, therefore, makes import at Nagpur unviable. ADC clearance is needed for importing raw materials in pharma units.
Varun Vijaywargi, Secretary General, VED, informed that the objective of the drug regulatory system in the country is to ensure availability of safe, effective and quality drugs, cosmetics and medical devices based on scientific excellence and best possible regulatory practices. The Central Drugs Standard Control Organization (CDSCO) has defined its mission as ‘to safeguard and enhance the public health by assuring the safety, efficacy and quality of drugs, cosmetics and medical devices.’ CDSCO has six zonal offices situated at Mumbai, Ghaziabad, Kolkata, Chennai, Ahmedabad and Hyderabad and three sub-zonal offices at Bangalore, Chandigarh and Jammu. It’s headquarter is situated at New Delhi.
Ajay Kathale, in the logistics business said, an NOC from the ADC Office of the Government is needed when one wishes to import medicines, OTC products or cosmetics and also some chemicals on commercial basis. The ADC’s NOC is obtained from the airport for which shipping documents like invoice, packing list and shipping bill have to be produced. This is necessary to ensure safety, efficacy and quality of the medical product manufactured, imported and distributed in the country.
There’s no ADC Office in the entire central Indian region, and the demand is that an office be opened in Nagpur, to cater to the Vidarbha and central Indian region, as this would act as a catalyst in boosting the economic development of Vidarbha. Currently, we have two major units manufacturing pharmaceuticals, who have generated employment for hundreds from the region. With the advent of the office of the Assistant Controller of Drugs in Nagpur, many major giants of the industry will find it lucrative to set their plants in MIHAN SEZ and adjoining industrial areas, thereby creating great employment opportunities for the deprived people of Vidarbha said Ganraj Rajgade in the logistics business.
Ulhas Mohile, exporter, informed that there are a number of pharmaceutical and chemical units in the region, which routinely import raw materials. The absence of the ADC office delays the process of customs clearance and also adds significantly to cost of doing business and the trouble of having to travel to Mumbai every time. An ADC office in Nagpur would mean this chunk of business coming here instead of having to go through the office in Mumbai. It’s not just the current, but future projections can be very huge too. The ecosystem is totally conducive here for setting up the ADC office with already a full facility in MIHAN and ICD.
VED therefore proposes that the ADC office be set up in Nagpur at the earliest.
VED has submitted the above proposal to Shri. Nitin Gadkariji, Hon’ble Minister for Road Transport & Highways who has forwarded the same to Dr. Smt. Bharti Pawarji, Hon’ble Minister of State for Health & Family Welfare, Govt. of India, in the belief that she would look into VED’s plea and take appropriate action to VED’s request and proposal.