The medium and small-scale pharmaceutical manufacturers have expressed concerns over stringent export NOC (no-objection certificate) requirements, warning that Indian exporters can lose their export markets to competitors such as China, Bangladesh and Pakistan.
At a time when Indian exports to the US are becoming uncertain, losing out South Asian, Latin American and African markets will jeopardise the entire pharma MSME sector, fear exporters.
“Export NOC should be only restricted to narcotic & habit-forming drugs and for other products, the same should be simplified and issues resolved immediately in consultation with all stakeholders. We wish to add here that the country is losing export business to other countries,” the Joint Forum of Pharmaceutical MSMEs Association of India wrote in its letter to to Health & Family Welfare Minister JP Nadda.
The exporters underlined that exports are not covered under the Drugs & Cosmetics Act. However, the Drugs Controller General of India (DCGI) has mandated export NOC requirements even for non-narcotic drugs. They argue that the recent changes have complicated export procedures. The requirement for certification from the National Regulatory Authority (NRA) of importing countries has emerged as a key hurdle.
“Several countries like Congo, Mali don’t have NRA or some countries have weak NRA. But there is a huge export potential. We can’t export to those countries as India doesn’t permit us to send pharma products without NRA certificate,” said Nipun Jain, CoA member, Pharmexcil. He stated Indian government mandates if exporters show NRA certificate from the US or European countries then they will be allowed to export medicines to those countries, where NRA is not there. “But it is not comparable as climate and demographics vary. Thus, medicines which will be applicable for the population in US, Europe, might not be fit for people in Latin America, South Asian and African countries,” added Nipun Jain.
Putting such restrictions will only push importing countries to buy from competitors based in China, Bangladesh and Pakistan. Other bottlenecks include restrictions on exporting medicines with shorter shelf life, despite demand from developing economies. “Also Indian government doesn’t allow us to export medicines like certain vitamins to these countries, that are banned in India,” added a founder of a pharma company.
Nipun Jain also warned that once India loses these export markets it will be very difficult to regain them.
“Several countries like Congo, Mali don’t have NRA or some countries have very weak NRA. But there is a huge export potential. We can’t export to those countries as India doesn’t permit us to send pharma products without NRA certificate,” said Nipun Jain, CoA member, Pharmexcil. He explained that Indian government mandates that if the exporters show the NRA certificate from the US or European countries then they will be allowed to export medicines to those countries, where NRA is not there. “But it is not comparable as climate and demographics vary. Thus, medicines which will be applicable for the population in US, Europe, might not be fit for people in Latin America, South Asian and African countries,” added Nipun Jain.
Lengthy clearance times for export NOCs, sometimes stretching into months, further exacerbate delays, leading to order cancellations. Nipun Jain also warned that once India loses these export markets it will be very difficult to regain them.