Even as the quality of generics becomes an overarching concern for regulators and consumers worldwide, India is working keenly on highly proactive initiatives to get its act together on the crucial APIs front.

In an unprecedented gesture, India’s drug regulator recently published an updated list of API-making CMOs that follow internationally accepted quality standards on its official website. The list displays the names of all the certified APIs that a particular CMO produces, as per different pharmacopoeial standards. Alongside basic info pertaining the CMOs, scanned copies of the ‘written confirmations’ (WCs) issued to the manufacturers endorsing quality of the products are also provided. The online documents have turned out to be a ready reckoner for companies across the world looking to source APIs from India.

The WCs were prompted by a new requirement for shipping to countries belonging to the EU. The new legislation, coming into force in July 2013, requires a WC by a competent authority nominated by the government of India that the API has been manufactured in compliance with EU-GMP standards.

Previously, the onus of certification lay with a Qualified Person (QP) of the EU-located company that intended to use the API, and exporters of APIs to EU countries held a Certificate of Suitability (CoS) issued by EU authority of the respective member states.

The new EU Falsified Medicines Directive aims to address the widespread concerns on quality of imported pharma products by laying down a system of control over the entire supply chain — manufacture and import for marketing, wholesale and retail distribution for pharmaceuticals.

Presently, the 27-member strong EU sources 70% of its API needs from India and China. Indian companies hold the highest number of CoS, according to an estimate by Thomson Reuters.

Bold Moves
India described the publication of a list of certified API suppliers as a landmark achievement that underlines the seriousness the government towards pharma exports. Pharma exports grew by 10.5% percent year-on-year to $14.6 billion during the financial year 2012-13, up from $13.2 billion, according to Pharmaceuticals Export Promotion Council (Pharmexcil), an industry body. Exports to the US grew $3.7 billion this fiscal year, up from $3.2 billion. UK stood in second place with exports worth $511 million.

Compliance with the EU directive is expected to have a very positive impact on API suppliers, as many of them aspiring to export to the developed countries shall, in the process of becoming compliant, upgrade their plants to World Health Organization (WHO) GMP standards, according a statement issued in this regard by the ministry of commerce and industry.

“In due course of time, online application filing and tracking system would be evolved to bring in sufficient expediency and transparency in the system,” said the statement.

Currently, India has 160 facilities approved by European regulators. Another 1,300 factories are certified by WHO. It also houses the highest number of U.S. FDA-approved manufacturing units outside of the U.S. Overall, there are about 8,000 manufacturing units across the country, according to estimates from the Drug Controller General of India, the country’s top regulator.

Keeping Tab On Imports
While insisting exporters adhere to quality standards stipulated by different markets, India is taking stricter measures to ensure the quality of API imported for domestic use, as well. In fact, DCGI started the process of inspecting facilities abroad supplying APIs to India several years ago. Subsequently, inspectors from the regulator’s office visited several manufacturing units located in China — the biggest exporter of APIs and intermediates to India. The regulator, however, could not complete all the inspections in the desired timeframe due to resource constraints.

Reports said the health ministry is currently evaluating recommendations by a Parliamentary Standing Committee to check samples of shipping at the port of entry itself. In view of rising concerns about the quality of products manufactured in the country, the panel attached to the ministry also suggested certification of quality for every batch of each API. The quality endorsement should be issued by the relevant drug regulatory authority of the country from which it is imported. Such a certification would help the regulator to take appropriate action against the overseas manufacture in case of non-compliance of quality standards.

Analysts say India’s initiatives to ascertain the quality of APIs for bulk drugs are in right direction. Reports forecast high-speed growth in API market in the Asia-Pacific region in the next few years. The growth will be fueled by increasing penetration in India and China coupled with low-cost manufacturing. A flawless implementation of regulations would propel India, which is considered the generic hub of the world, to even faster growth.