India has announced plans for a new short-term strategy aimed at boosting pharmaceutical exports, and has also set guidelines for domestic drugmakers to comply with a European Union (EU) directive on imports of bulk drugs into Europe.The new initiative to encourage drug exports is being introduced because of government concern over their slow pace of growth in US dollar terms. It has become clear that the target set for exports of pharmaceuticals to have reached at least $25 billion by March 2014 will be difficult for the industry to achieve, and the strategy will be put in place to help enable the sector to achieve this goal by March 2015, according to the Pharmaceutical Export Promotion Council of India (Pharmexcil), an agency of the Commerce and Industry Ministry.
During 2012-13, India's exports of pharmaceuticals increased in local currency terms by 25% to reach 80,000 crore rupees. However, when expressed in US dollars, exports for the year amounted to £14.5 billion, representing an annual rise of 9%, which is a considerable drop from the 22% dollar-terms growth reported two years earlier, says Pharmexcil.After reviewing the sector's export performance, "it is noted that the target figure of $25 billion exports would be difficult to achieve by the projected timeline of March 2014. In order to ensure achievement of the targeted $25 billion at least by March 2015 (one year later), the Ministry is keen to develop a short-term strategy plan," said the agency in a statement.
Meantime, the government has also announced new guidelines for drugmakers to comply with an EU directive on Good Manufacturing Practice (GMP) standards for active pharmaceutical ingredients (APIs) imported into the EU.The directive was issued on June 8, 2011 and comes into force on July 2. After that date, India will be required to certify that locally-made APIs being imported into the EU comply with European quality standards. At present, such certification is carried out by the importing nation.
The new legislation will require written confirmation by a competent authority nominated by the Indian government that the API has been manufactured in accordance with EU GMP standards. The authority will also give written confirmation that the facility where the API is produced is subject to control and enforcement of GMP standards and that it is equivalent to those in EU member states."Various EU industry members have been expressing their concern about the ability of India to comply with the new procedure by the deadline of July 2, 2013. However, the government of India is optimistic that its pharma industry would be able to meet regulatory requirements within the given timeframe," according to a statement issued by the Ministry.
"India has demonstrated its keenness to meet international requirements for exports of pharmaceutical products yet again by taking timely action for complying with the new procedural requirements of the EU," the statement adds.