Saturday, January 23, 2010

ASEAN harmonises drug registration norms, CTD filing to be mandatory from 2012

Saturday, January 23, 2010
Gireesh Babu, Mumbai

In an effort to harmonise the pharma regulations through the ASEAN Common Technology Dossier (ACTD), the Association of Southeast Asian Nations (ASEAN) will mandate filing of the dossier as the only regulatory filing for the pharma industry to get approval for business in the 10-member states from 2012.

The move will help the Indian generic pharma to grab the US$ 1.4 billion ASEAN market through a single window registration. However, it would also pose a threat for the country's drug research and clinical trial industry in near future, if the government of India is to neglect the need for change in regulations in tandem with the global requirements, say experts.

The ASEAN, consisting of Singapore, Malaysia, Indonesia, Philippines, Thailand, Vietnam, Brunei, Myanmar, Cambodia and Laos, has implemented the ACTD for the member-countries from January 1, 2009. The harmonization is designed such as to extend to all areas of the pharmaceutical sector from quality testing, raw materials to manufacturing and marketing.

The harmonisation has three principal aims – creation of a transparent regulatory process, standardisation of regulatory requirements and cutting short the timeline for regulatory approvals by extraditing requirement of duplicate studies for each member states.

The move is expected to allow more time and resource for the drug companies as an advantage to hasten the research and development processes for new drugs. Though the CTD of International Conference on Harmonisation (ICH) will be accepted for registrations for the first three years from 2009, the member countries would mandate ACTD filing for pharma products from 2012.

With more than 60 per cent of the total market consisting of generic drugs, the Indian pharma firms can grab the opportunity to market their generic products in all the member countries through a single approval. The harmonisation project, along with the new India-ASEAN Foreign Trade Agreement (FTA) offers a better opportunity for the Indian pharma exporters, said an industry expert from Malaysia.

The association expects that the harmonisation of standards will help the member countries to lower the cost and increase the quality and availability of medicines in the region. It also aims to formulate rules for importing medicines, to ensure that the region will only have high quality drugs in the market. Rejection or alert on a product in one country will be applicable for all the member countries.

However, the new regulation, which would hasten the research and development projects, coupled with the cost benefits and economic strength of these countries would tend the global research outsourcing firms to shift their focus from India to ASEAN nations, comments the source on condition of anonymity.

The buying power of people in these countries is almost 13 times more than India and the economic scenario is also cost effective for the overseas firms. Many of the Indian pharma firms and clinical research organisations (CROs) have already set their research operations in Malaysia and Singapore. The recent decline of CRO industry in India, which is reported down 30 per cent from last year, is a hint to the upcoming trend of shifting of research outsourcing jobs from India to ASEAN nations. “Almost 50 per cent of the 30 per cent business lost for CROs in India has benefited the ASEAN nations,” he added.

The expertise in the biopharma and cell therapy with well set regulations for these segments are an added advantage for ASEAN nations in contract research activities. The lack of proper guidelines and regulations for biopharmaceuticals and stem cell therapy in India will affect the country's drug research industry in long term, if the government does not address the issue promptly, said a clinical trial expert in Mumbai.


surajit roy said...
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Vishal20 said...
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