Indian pharmaceutical industry is growing approximately by USD 2 Billion every year and by 2020 it could be USD 55 Billion. Just conceptualising vision 2020 and then vision 2030 is not enough unless until vision documents should be shared to all manufacturers and exporters. In a survey, conducted in 500 pharma stake holders mix of pharma manufacturers and exporters to know whether they know vision 2020 or not and the result was big zero.It means vision designing is very easy but its implementation is very challenging. Pharma industry is skilled industry and non pharma people cannot understand the issues related to this industry hence government servant or ministers are not skilled enough to give future to pharma industry. There should be pharmaceutical minister in place along with pharma skilled government servants to design vision document and then they can guide as how to implement upto the scheduled M level manufacturers and small exporters. Pharma industry is growing day by day by self help of industry people and there is no contribution of government. Rather than supporting to pharmaceutical industry, government is giving lethal dose time to time. There are many challenges pharma industry is facing right now and need booster live saving dose to be global leader in formulations and API. This industry is giving 5 million jobs alone and it could be 10 million if following steps can be strongly taken care, these steps are as follows:
1. Export Registration: Try to understand cost involved in product registration in foreign countries. Taking permission of administrative documents such COPP, Product Permission, Free Sale Certificate, dossier compilation, artwork development, sample manufacturing, PSUR compilation, Risk Management Planning, PSMF, Bioequivalence Study, Clinical Study, Pre-clinical Study, procuring impurities and reference standard. All these require more than Rs.15, 0000 and same amount is required as product registration fee in most of the semiregulated countries. If government can give interest free loan for registration of products only then industry can grow by at least USD 6-8 billion per year. Company can return back loan amount in 3 commercial consignments.
2. Frequent Policy Making: Stop frequent policy introduction which has no relevance and makes product costlier. For example government tried to implement bar code compulsory in export. Let the importing countries decide their norms and exporters are ready to follow.
3. API Prices: NPPA controls prices of formulations without controlling prices of API. They revised rates in April, 2017 last time for most of the products. Every month prices of formulations should be reviewed and it would be justice with industry and not the mercy.
4. Prices fixation of B.E and Clinical study: Like NPPA there should be a government body for price fixation of Bioequivalence study and clinical trial study. Some CRO is charging 6 lakh for bioequivalence study, some are charging 12 lakh and some are charging 20 lakh or more. All these expenses add to product.
5. Justice in court: Now industry people are forced to go to court, sometimes for fixed dose combination and sometimes for other reasons. There are thousands and lakhs of families are dependent on business bandwagon and hence there should be an arbitrator to resolve the issue in most of the cases out of the court. Court is for criminals and not for the business community for minor issues. As of now 51,000 cases are pending since more than 30 years in all over India.
6. Acceptance of Indian Pharmacopeia: Government and private players should join hands together for acceptance of I.P globally, if India can accept British Pharmacopeia, United State Pharmacopeia then why not they will accept I.P. Government should take a stand. If some country put embargo on I.P then we should put embargo on their pharmacopeia.
7. Academia & Industry Coordination: There should be a permanent platform where academia can showcase their innovation and industry people can buy that innovation. Now academicians are having patents with them but those are not commercially viable because there are no platform as such.
8. Generic to Patent Era: Being global super power with generic medicine is really hat off to pharma industry for huge success. Time has changed, its time for smart working hence we all have to use pharmacy colleges as research laboratory, the way European and American are doing since long time.
9. Skill based Education System: world is facing serious skills crunch and on the other hand there are huge unemployed youths. Knowledge and skills should go hand in hand and then youth can play as a growth engine for the industry.
10. Commercialise Universities: Stop giving aid to universities and guide them to earn as much as they can then only their inner strength will come forward and innovative products will come into the market place. It is already there in Europe.
Conceptualise and documented by 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.
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.
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.
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