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
For every challenge we face - unemployment, poverty, crime, income growth, income inequality, productivity, competitiveness - a great education is a major component of the solution. From Jawaharlal Nehru to Narendra Modi or any prime minister of India cannot fulfil commitment of employment because they do not know how. They do not know demand supply chain. Indian pharmaceutical industry is providing 10 million jobs for skilled and unskilled workers.
Trump over and again creates buzz of false nationalist to grab the media coverage. It is trend now globally, politicians talk in all front without validated data. We strongly disagree with the observations made by USTR that India and China are involved in manufacturing substandard generic medicine. USTR is The Office of the United States Trade Representative is the United States government agency responsible for developing and recommending United States trade policy to the President of the United States.
Honourable regulators, legal advisors and manufacturers please justify as why stability is mandatory to get product permission whether old drug or a new drug. Sharing facts and asking questions as why it so happening into the pharmaceutical industry over and again. Drug and Cosmetic Act is in place to regulate the pharmaceutical industry then why everyday new circular is coming to the industry people.
E-pharmacies are recent entrants in the Indian e-commerce industry landscape, with it receiving increased attention from government and investors in the last three to five years. Today, the E-pharmacy market potential is worth over a 3,500 Crore with more than 35 startups assisting the growth of this segment in various regions of India. Inspite of being a novel segment in the Indian E - commerce industry, it is anticipated to grow at a CAGR of over 20%, crossing the 25,000 Cr mark by 2022.
Your email address will not be this published. Required fields are News Today.