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Task force for simplifying regulatory forms & formats forms 4 sub-committees

Suja Nair ShirodkarThursday, December 4, 2014, 08:00 Hrs  [IST]

The Task force set up by the Central Drugs Standard Control Organization (CDSCO) for examining and recommending changes for simplifying forms and formats, constituted four sub committees last week. The sub committees will be assisting the task force in its work by recommending various regulatory functions to expedite the whole process.

A highly placed source from the centre informed that the sub committees have been set up on the basis of four categories namely, import, new drug and clinical trials; manufacturing; trade, cell and finally laboratories. All the members of the sub committees which was constituted during the second meeting since the inception of the task force will function under and directly report to Dr R Chandrashekar Rao, deputy drug controller of India (DDCI), who is also the chairman of the task force.

It is understood that the each sub committee consists of four to eight experts from the drug regulatory department, industry likewise depending on the committee they are part of. An insider closely associated with the process informed sub committee for import, new drug and clinical trials consist of six members namely Dr Bangarurajan, deputy drugs controller, west zone; S W Deshpande, retired joint commissioner, FDA Maharashtra; Dr Suresh Menon representative from OPPI; Arun Mishra, CII representative; Kuldeep Wakhloo representative from FICCI and Sunil Kulshreshta from CDSCO. While the sub committee for manufacturing consist of seven members which includes Selvaraj, retired drugs controller from Tamil Nadu; Uttarwar, ex joint commissioner from FDA Maharashtra; Dr H G Koshia drug controller of Gujarat; N Marwah drug controller of Himachal, Salim A Velijee, drug controller from Goa; Rajiv Nath from AMIED and Dr Kiran Marthak from IDMA.

Representatives from trade and cell includes four members P K Jaggi, ex deputy drugs controller; D K Shringi, ex drug controller from Rajasthan; Selvaraj, retired drugs controller from Tamil Nadu and Satish Gupta, retired drug controller from Jammu and Kashmir. While R A Singh, director RDTL Chandigarh; Hariharan, director, I/C director CDI Kolkata; Dr Saurab Arora, representative from a private drug testing laboratory and Dr Satyanarayana from Sipra Labs Hyderabad comprise of the four member sub commitee for laboratories.

Interestingly all the expenses incurred by the task force will be sourced from the budget of the Indian Pharmacopeia Commission (IPC).

 
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