Department Of Commerce Working With CDSCO For Promotion Of Newer Products For Exports


New Delhi : The Department of Commerce (DoC) is working with the drug regulator for the promotion of newer products such as gene therapy, biosimilars, and specialty drugs to drive the next phase of growth in exports, simultaneously working on setting up footprints in under-penetrated international markets.

There is a huge market opportunity emerging for Indian manufacturers in the untapped but potential markets of Latin American Countries, Africa and Asia. Besides, on account of its skill, cost and delivery advantages, there are strong growth prospects for India as an outsourcing destination for Contract Research and Manufacturing Services (CRAMS), clinical research, biotechnology, bioinformatics, among others.

“Department of Commerce is working with CDSCO for promotion of newer products such as gene therapy, biosimilars, and specialty drugs to drive the next phase of growth of exports,” said the DoC, in its annual report for the year 2021-22.

DoC has also been closely interacting with global regulatory agencies and Trade Ministries, Indian Missions to resolve the regulatory and market access issues faced by Indian industry in accessing foreign markets. The delay in inspections and issuing of GMP certificates by global regulatory authorities such as US Food & Drug Administration and European Medicines Agency due to Covid-19 situation were taken up strongly to expedite inspections and facilitate exports, it said.

The export of drugs and pharmaceuticals during the period between April and December, 2021, was at $18.18 billion. During 2020-21, Indian pharma exports grew 18.19% to reach US$ 24.46 billion, spurred by strong demand for the country’s generic drugs. The industry registered its best export performance in value terms last year despite the global pharma market shrinking by 1-2% in 2020.

Drug formulations and biologicals remained the second-largest commodity exported by India. India’s top five pharma exports destinations in 2020- 21 were USA, South Africa, UK, Nigeria and Russia. Exports to the U.S., Canada and Mexico recorded a growth of 12.6%, 30% and 21.4% respectively.

Under the onus of the Pharmaceuticals Export Promotion Council of India (Pharmexcil), whose membership strength was around 3881 as on March 31, 2021, the efforts to explore new markets will be taken up.

The DoC is proactively working towards establishing footprints in under penetrated/ potential international markets – Japan, Korea, China, Africa, and Indonesia etc.

Pharmexcil’s Brand India Pharma project, launched since 2012, is working towards promoting Indian pharma products in the international markets and emphasis is being given on “Made in India” logos to highlight the potential of the sector and to project India as a preferred destination, due to quality and affordability.

The Council has entered into Memorandums of Understanding with Research Associations and Councils of various countries such as Korea, China, Philippines, Ukraine etc. to promote bilateral trade in pharmaceuticals.  Following sustained efforts, Indian Pharmacopoeia has been accepted by Afghanistan and Ghana.

“Mutual Recognition Agreements between the regulatory authorities of focus countries are also being followed up on a priority basis. Recognition of Indian Pharmacopoeia by trade partners such as South Asia, Africa and Latin American regions are also a priority,” said the report.

To ensure that exports of spurious/fake/ substandard medicines do not take place from India, the system of track and trace for export of pharmaceutical formulations from India has been introduced with effect from February 10, 2011 in phases.

The industry has been able to adopt the system of barcoding on the secondary and tertiary levels of packaging, and also on primary level on a voluntary basis, it said. A technology neutral and user-friendly web portal ‘iVEDA’ (Integrated Validation of Export of Drugs and its Authentication) has also been developed by Pharmexcil and launched for authentication of drugs exported from India. The beta version of iVEDA portal has been launched on 24th June 2020.

Various Production Linked Incentive Schemes have been launched by the Centre to reduce dependency on import of Active Pharmaceutical Ingredients (APIs) and other raw materials.

The Department of Commerce, which supports Pharma industry through its scheme of reimbursement of product registrations abroad upto Rs 2 crore per year, played a hand holding role to the industry in overcoming constraints and disruptions caused due to COVID-19 and taking up issues with concerned line Ministries for resolution- especially logistics and supply chain disruptions.


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