It is an old adage “Rome was not built in a day “Similarly global super power tag not attached to Indian Pharma Industries in a day. Regulators worked day and night in policy making, implementation and coordination with industry and global regulatory agencies for better administration. Two Singham, Dr.Surender Singh & Dr.G.N.Singh made CDSCO proactive and stronger in terms of transparency and administration.

                 Dr.Surender Singh extended wings of CDSCO across the world, whereas Dr.G.N.Singh stopped unwanted FDC approval and banned irrational FDC. Dr.G.N.Singh introduced drug safety guideline whereas Dr.Surender Singh made mandatory clinical trial and bioequivalence study for new drug approval. Now Dr.Ishwara Reddy, a current DCGI will take this legacy to new height.  Rules are made for the comfort of industry and not for discomfort. Rules and act are mandatory to administer industry but frequent policy making gives loss to nation and degrowth to industry. 

                 Policy Regarding Packing Material: Implemented from 1st April, 2019 and now every company has to follow. Now onwards generic name should be bigger in size in comparison to brand name. Small scale industries are already in loss and mostly are in position to shut down because of many reason and now they are not in a position to accept one more loss, packing material loss. Allow them to use that ready packing material in 6-12 months time so that they can survive and can utilize packing materials. It’s a rule of India when a company relocate from one state to another state then manufacturer can utilize previous ready packing materials upto 12 months. 

                Policy Regarding New Drug Approval Fee: There will be no double standard policy, one for industry and another for regulatory agency. Manufacturer can increase MRP 10% only after one year then how come regulatory agency can increase fee Rs.15000 to 2, 00000, you should increase Rs.1500 only @ 10%. Through this autocratic approach are shutting down many small scale industries and increasing unemployment. Think about it and do the needful correction without any delay.  Policy Regarding Product Permission for Export: One side you are getting credit of doing ease of business and another side you teasing also.

               You removed export NOC from CDSCO but still export NOC is there in SLA level. SLAs are not giving product permission for export in most of the states those product not approved in India. If you will not give product permission then how come manufacturer will produce test product for COPP. Neither you are guiding nor you are listing as what to do.  Policy Regarding Product Permission for Domestic Market: How will new manufacturers will survive without product permission especially those who are first time manufacturing? First time manufactures are more than 300 alone in Gujarat. They invested lots of money on loan and they were ready to get back but new policy pushed them to go back in loss. Think about new manufacturers otherwise many families will suffer financial loss and jobs. 

               Policy Regarding Product Registration for Export: Government is refunding back 50% of upto 2.5 Crore investments. This strategy is manual in approach and big pharma exporters will be getting benefits and not the small scale industry. Fund 2.5 crore to budding exporters or small scale exporters and get back refund in 10 instalments. Industry does not want any rebate. If you will do that then export will grow leaps and bound.  Currently pharma industry is giving 10 million jobs across the world and if government will introduce policy in coordination with industry then industry can give 20 million jobs. Currently, Pharma industry is 3rd largest earner of foreign currency and it could be the largest earner of foreign currency in days to come.

              Think before policy making that participation of industry should be must, there should not be loss to the nation when you are introducing new policy and there should not be unemployment because of the wrong policy making. Also requesting stop frequent policy making, it shows that regulator are not planned as what to do. Let the businessmen concentrate on business generation and employment generation. Businessmen are the best social worker and nation builder. 

             Yes smart regulators are the need of the hour and help industry grow in a smart way. We require smart regulars or call them smart facilitators. We have to think about the global citizen because we are pharmacy of the world and frequent policy gives wrong impact on global citizen.

Mohammad Shahbaz Alam