India envisages exports expansion in Latin America and places renewed focus and investment on safeguarding the quality of drugs produced
India has made a robust commitment to implement a range of regulatory and quality measures designed to safeguard its increasing market share in developed economies. The pharmaceutical industry and the government are making sustained collective efforts to maintain the export growth trajectory, says IBEF (India Brand Equity Foundation).
Around 220 countries are sourcing pharma products from India, taking total global exports close to US$15bn in 2013-14. Argentina has recently fully opened up its $6bn drug market to Indian companies, increasing the scope to supply finished formulations. With India now on the list of countries that can supply medicines to the Argentinian market, India’s current contribution of around 8% to the Latin American region is expected to grow substantially in the long term.
On a macro level, India's top 20 pharmaceutical companies are expected to increase capital expenditure by 40% to more than Rs 50,000 crore ($8.3bn) by 2017-18. The investment is expected to be directed towards supporting regulated markets, to take advantage of substantial patent expiries expected in the medium term and an ever increasing demand for generics. The top 20 Indian pharma companies contribute close to two-thirds of the country's total pharma exports.
In conjunction with this, the Indian government together with the pharma industry has taken measures to create a more export friendly environment. India is one of the first countries to launch Trace and Track for its pharma products. The system involves affixing barcodes on the primary, secondary and tertiary levels packaging labels in phases in line with GS-1 global standards.
The barcode helps in tracking and tracing the origin of drugs, which in turn minimises the risk of genuine drugs being considered sub-standard or counterfeit. The system is already in place at the secondary and tertiary level of packaging currently.
India looks at healthcare as a holistic issue rather than just commercial business
'Quality is a major focus for pharmaceutical exports from India,' said Mr Sudhanshu Pandey, Joint Secretary, Department of Commerce, Government of India. 'India looks at healthcare as a holistic issue rather than just commercial business.'
The Indian Department of Commerce has been following a zero tolerance policy for maintaining high quality standards in Indian pharma exports. To address the issues from the developing markets, India has enhanced its engagement with the regulatory authorities.
For instance, a technical team was recently sent to Vietnam, including representatives from Central Drugs Standard Control Organization (CDSCO) and Pharmaceuticals Export Promotion Council (Pharmexcil). The team held in-depth meetings with counterparts to understand the issues, and they are expected to extend this initiative in the coming months to other major developing markets.
Additionally, India has put in place a mechanism for filing complaints about pharma products from India. The Department of Commerce has appointed a nodal officer who will be responsible for handling such complaints, working closely with the respective mission. An international cell has been set up in CDSCO with 10 dedicated inspectors to handle the cases reported from export markets.
Quality is a major focus for pharmaceutical exports from India
Pharmexcil has also taken several significant initiatives involving the various stakeholders to improve the quality mechanisms of Indian pharma products. The Council plans to organise workshops and seminars to keep the Indian pharma industry aware of the changing regulatory regime in the export markets.
'We have recently started an International Knowledge Exchange programme under which we invite members of the regulatory authority from the export market and facilitate their visit to Indian academic institutes, R&D centres and meetings with senior government officials,' said Dr P V Appaji, Director General, Pharmexcil. 'Officials from Egypt and Kenya visited India and we plan to invite regulators from GCC and ASEAN region during this financial year.'
The recent measures taken by the Government of India and the other stakeholders are expected to reinforce India’s credibility as a responsible healthcare provider. With the opening up of new markets and continued investments from Indian pharmaceutical companies, the global pharma industry is expected to continue to benefit from the strong talent base and cost efficient manufacturing capabilities that the country offers, states IBEF.