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‘We expect the new govt to reduce regulatory intervention’


BR Sikri, Chairman, Fope

First let me highlight the good things done by the present government.:

  • Recently agreed to publish SQ (What is SQ) also in addition to ‘Not of Standard Quality’ NSQ which was pending demand of HDMA.
  • Requirement of Form 29 for products being already marketed and no more new drug, is dispensed with.
  • Introduction of Sugam Portal to ensure data is available with the government and goal towards ease of doing business.
  • Agreed to conduct regional level workshops to solve many outstanding problems at the state level.
  • Streamlined approval process of new drugs, vaccines, etc.
  • Recent notification of clinical trial with lot of clarity.
  • Regular conducting of subject expert committees and IND committee meeting for timely evaluation of new drug applications.
  • Formation of pharma forum
  • File tracking system for applications for ascertaining the status
  • Simplification of procedure in lines with ease of doing business by delegating powers to SLA, port office, zonal offices
  • NOC for export of unapproved, banned drugs for export, import of small quantities of drugs for personal use and import of dual use items.
  • Extension of validity period of COPP from two years to three years as per demand of the industry to boost export.
  • Simplification of procedure at port offices for expeditious clearance of export consignment
  • Setting up of a Public Relation Office with dedicated staff at CDSCO HQ.
  • Publication of guidelines for bio-similars, GDP, GCP, GLP, new drugs

Future of pharma industry

In spite of frequent regulatory intervention, the pharma industry’s future is very promising and bright and demand will rise dramatically with the following reasons:

  • Global population increase
  • Changing lifestyle of western world in particular and India as a special case.
  • Many barriers to free trade have been removed and helped in bringing growth to global trade.
  • Presently, 195 Countries are depending on us and we are proud about producing  quality and affordable products at affordable price.
  • In India, there is a huge market potential to the industry. With technology advancement also the industry is only able to tap 17 per cent of the rural market out of 65 per cent. Therefore, there is scope to penetrate in remaining 48 per cent market in years to come.
  • Govt of India announced Health Policy wherein one percent of GDP is going to be 2.5 per cent by 2025
  • Increase in the percentage of disposable income of Indian population
  • Large number of patented product of pharma and bio-similar are going to be off patent very soon.
  • Free distribution of medicines of unidentified medicines through 1500 Wellness Centre
  • Increasing trend of population of elderly person
  • Rising healthcare spending by individuals
  • Rapid urbanisation resulting in increase in life style related disease

Ayushmaan Bharat project will also increase demand of medicines. We expect the new government to reduce regulatory intervention and consolidate the existing policy decisions so that the industry can focus on production, quality, efficacy and export.

Expectations from the government

  • Reduce frequent regulatory intervention.
  • Consolidation of existing policy changes.
  • To give moratorium to the industry from further changes in regulatory system so that it can focus on increasing production with quality efficacy and affordability into consideration.
  • To give financial assistance to MSMEs to increase exports.
  • To conduct regional level workshops with industry and SLAs.
  • To resolve many chronic problems like FDC, implementation of Sugam Portal.
  • To give more focus on rare disease and orphan drugs.
  • To consider Schedule-M upgradation as guiding document for three years and not to make it mandatory.

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