The new pharma city coming up here will have a separate drug control unit for speedy clearance of regulatory requirements.
The Drug Control Department (DCA) is also going the US FDA way by promoting specialisation of inspectors in all verticals of manufacturing for better efficiency.
“The decision has been taken to set up an exclusive unit in the upcoming pharma city right from day one,’’ Akun Sabharwal, Director, DCA, Telangana told BusinessLine here.
The unit will be headed by an officer of joint director cadre and work along with manufacturers to make it more ‘industry friendly’.
The Telangana Government had recently announced plan to develop an exclusive pharma zone on about 11,000 acres near Mucherla in the neighbouring Rangareddy district with an in-house pharmaceutical university and research facility.
The land acquisition modalities for the project are being examined by the Government.
Hyderabad has about 500 pharma and biotech companies, including majors like Dr Reddy’s Laboratories and Aurobindo Pharmaceuticals.
The Department of Industries, Telangana, is expecting to see significant investment in the new city by the existing companies as well as new investors.
Licence for drug makers
A drug control unit within the premises will help the pharma industry.
As many as 18 licences are to be obtained from the department by pharma manufacturers.
The department has also been offering a provision for self-certification in some areas such as non-conviction certificates to be attached by each pharma company, while competing for global tenders, according to Sabharwal.
The DCA has also been restructured to nurture specialisation among officials who inspect various manufacturing units.
“Till now, there have been no special skills for our inspectors. An official who inspected a vaccine company also visited a totally different facility such as a devices manufacturing unit. To avoid this and nurture specialised skills, we have rejigged the organisational structure in the US FDA manner,’’ he said.
In the old set up, the DCA was divided into three wings of sales, manufacturing and laboratory.
Now, six new verticals have been introduced in the manufacturing wing, namely, drugs (including APIs), cosmetics, blood and biologics, vaccines, medical devices, and animal and vet products.
Via : thehindubusinessline.com