Indian pharmaceutical companies exporting medicines worth $1 billion to at least a dozen countries like Brazil, Mexico, China and Germany are finding non-tariff barriers, in the form of discriminatory treatments, hampering their export growth prospects.
While exporters to Brazil and Mexico complain about the recent increase in import tax to 14 per cent, prohibitive registration charges of about $20,000 for each product and a waiting period of 18 months are the major problems faced by them in China.
In a representation to the commerce ministry, pharmaceutical exporters have said the official fee for registration in China comes to around $10,000 per product and another $8,000 to $10,000 is being charged as facilitation fee by local Chinese companies.
They also said Brazil and Mexico, which used to have nominal import duties till last year, raised this duty/import tax substantially without applying a similar duty hike on local manufacturers. "This has affected the competitiveness of Indian pharma as prices of imported drugs have gone up substantially in Brazil," DB Mody, chairman, Pharmaceutical Export Promotion Council (Pharmexcil), said.
Mody also pointed out that Brazil has introduced different types of plant approval procedures to the benefit of domestic industry.
"According to the recent changes, good manufacturing practices (GMP) guidelines have become very strict. Before filing any dossier, a pharma exporter for formulations to Brazil is necessary to obtain GMP from ANVISA (FDA of Brazil).
This means a heavy fee, inspection by ANVISA inspectors and time. On the other side, a local manufacturer can work with just local VISA approvals and need not have to obtain ANVISA GMP compliance," he said.
The exporters complain that Nigeria, the seventh largest medicine destination for India has banned some specific drugs and formulations to protect the domestic pharma industry. Similar is the complaint against Pakistan as that country has banned the import of Indian bulk drugs that are locally produced, though such restrictions do not apply to other exporting countries.
The major complaint against EU is in relation to the import of Hops (Humulus Lupulus Extract) by the European community.
According to this legislation, Hops imported into Europe and which is not grown in Europe cannot be imported into Europe unless it is accompanied by an equivalence certificate issued by the specified authorities of the exporting country, and India does not figure in the list of specified authorities for issue of equivalence certificate, whereas China is included, exporters allege.
The exporters are also unhappy with the pre-conditions put up by countries like Libya, UAE and Albania before Indian exporters can supply medicines from their facilities.
