Understanding woes of the pharma manufacturers in travelling all the way to Delhi to submit the applications for the FDCs to prove their safety and efficacy, the Drug Controller General of India (DCGI) informed the manufacturers that they can file application for the same, before the deadline, in the nearest zonal or sub zonal offices.

Through this initiative, the DCGI hopes to encourage more manufacturers to follow the mandate passed by the Centre which requires all the companies to submit, Form 44 along with other requisite supporting documents to prove the safety and efficacy of the FDC on or before August 31. Failing to which, Dr G N Singh, DCGI, warned that such FDCs will be banned and prohibited from manufacturing and marketing within the country.

Dr Singh said, “The safety of the patients is our utmost concern while at the same time we want to ensure our full support to the industry and hope that they will collaborate with us in achieving our vision and mission for safeguarding the interest of the patients of this country. It is with this view, that we have decided to relax the norms relating to submission of the application as it was found that the companies were finding it extremely cumbersome and difficult to tackle the strain of travelling all the way to Delhi. Thus keeping in mind, the better interest of the stakeholders, we have taken this decision to allow them to submit their application at the nearest zonal or sub zonal office within the prescribed time frame.”

As of now, the manufacturers were required to travel to Delhi to submit the application at the CDSCO’s office. However, the DCGIs direction to the zonal and the sub zonal offices to accept the application comes as a welcome move and a huge relief to the scores of the pharma manufacturers across the country. Especially, the small scale manufacturers of the country who were finding it very difficult both economically as well otherwise to travel all the way to the centre to submit the application are found to be very content with this move albeit a little late.

Earlier in January this year, the DCGI had directed the State drug controllers to ask the concerned manufacturers to prove the safety and efficacy of such FDCs within 18 months. Failing to get the expected response from the companies to prove the safety and efficacy of such FDCs, the DCGI had revised the deadline given to the manufacturers in this regard to August 31.