In order to reduce the financial burden of around 300 US FDA approved pharma facilities in India, Indian Drug Manufacturers Association (IDMA) has asked the US Food and Drug Administration (FDA) to reduce the annual fee on approved Indian pharma facilities by 50 per cent.
This request was made during the discussions between the DCGI and the US FDA Commissioner during her recent visit to India between February 10 and 18, 2014 for strengthening cooperation between the two countries on regulatory compliances. A proposal which is in the draft stage will be sent to the US FDA by IDMA following the request.
The fee to be charged on an annual basis came into effect from October 2, 2012 under the Generic Drug User Fee Amendments (GDUFA). The US regulations require the exporting drug companies to pay user fees to supplement the costs of reviewing generic drug applications and inspecting facilities.
Says S V Veerramani, president, Indian Drugs Manufacturers Association (IDMA), "We would be making a proposal to the US FDA following this request shortly which also aims at offering participation to around 100 small bulk drug companies who are planning to make an entry in the US market. The introduction of a facility fee of $230,000 annually for a US approved Indian facility in formulations and $60,000 for a bulk drug facility which did not exist earlier can be a deterrent for companies looking at regulated markets."
He further adds that filing for an Abbreviated New Drug Application (ANDA) costs around $50,000 and a DMF Dossier costs $32,000.
As per US FDA, these fees help it reduce the backlog of pending applications, cut the average time required to review generic drug applications for safety and improve risk based inspections.
The proposal is relevant as US FDA commissioner Margaret Hamburg spoke about FDA's plans to hold multi-year capacity building workshops for domestic regulators to understand US FDA standardised processes of GMPs and cGMPs and help Indian pharma companies for audit readiness and inspections. The workshops are planned to be held in Ahmedabad, Gujarat, Hyderabad, Chandigarh and Goa.
With a striking spike in the frequency of US FDA's regulatory action and India accounting for 40 per cent exports of generics to the US, Indian life science companies are in dire need to achieve regulatory compliance through training on GMP compliance, consent decree, Form 483, data integrity and quality management systems. This would also entail maintenance of electronic records for inspection readiness and lead to additional costs in the form of training.
"We are also planning to seek a role in offering our services and support to US FDA and Indian pharma companies on conducting mock audits and training workshops for audit preparedness of Indian facilities. We are awaiting a response on this subject from the US FDA," concludes Veerramani.