US, EU slowdown may keep pharma export growth at 10%: Official

Pharmaceutical exports from India is expected to remain in the range of 10 to 11% in the current fiscal as slowdown in some of the key markets such as North America and Europe continue to cause concern to exporters, a senior government official said.

P V Appaji, Director General of Pharmaceuticals Export Promotion Council (Pharmexcil), under the Ministry of Commerce and Industry, said most of the Indian pharma exporters have secured written confirmation (WC) certificates from the Drug Controller General of India well in time to meet the new European Union (EU) regulations on active pharmaceutical ingredients (API) imports.

"This year, there is a slowdown (in some markets). We are looking anxiously. We will have to still ascertain the position. More or less it (pharma exports growth) can be in the same range. The exact position would be clear in the next few days," Appaji told PTI.

The growth of Indian pharma exports during 2012-13 halved to 10.55% over previous year to $14.6 billion. During 2011-12 the exports stood at $13.2 billion registering a growth of 23.7% over 2010-11.

Major markets for Indian pharma exports USA and Europe underperformed during FY13 causing a big dent to exports.

While exports to North America grew 13.44% to $4 billion, exports to Europe grew marginally by just 1.2% to $2.63 billion. A year-ago, exports to North America and Europe registered a growth of 33% and 30%, respectively.

"There was some business loss from USA and Europe markets. Last two to three years US market growth was good. By the year end we expect that the USA market will become normal," Appaji added.

Echoing similar views, Sarabjit Kour Nangra, VP Research Specialist pharmaceuticals, Angel Broking, said the industry is expected to do well in terms of exports to USA this year.

"None of the companies we are tracking with have expressed any apprehensions over exports. More or less it should be healthy growth," Nangra said.

On the new EU Regulation on API exports, Appaji said as many as 170 companies have secured WC certificates in time and there is no hindrance in exports.

The European Medicines Agency in its directive said effective 2 July 2013, all active substances manufactured outside of the EU and imported into the EU must be accompanied by a written confirmation from the competent authority of the exporting country.

The concerned authority would confirm that the standards of good manufacturing practice (GMP) and control of the manufacturing plant are at par with those in the EU.

In case of India, Drug Controller General of India is the competent authority to issue WC, Appaji said.

"DCGI is the notified competent authority for certification of goods. Pharmexcil has followed up with the DCGI in preparing guidelines and circulate it to member companies," he said.

As per the guidelines, the industry is submitting applications and zonal offices of DCGI are examining the applications and forwarding them to the main office.