With a view to study the problems faced by the Indian pharma exporters that may impact access to quality based affordable medicines in the US, the Secretary of US Department of Health and Human Services (HHS) Kathleen Sebelius recently visited India to have a high-level meeting with select representatives from the Indian Pharmaceutical Alliance (IPA) in Mumbai. The aim behind this closed door meeting was to address major issues concerning counterfeit medicines and non-tariff barriers to exports among others.

This strategic meeting highlights the US government’s initiative in continuing a strong business relation with India and points out at the importance of the Indian pharma industry for the US as producer of low cost, safe and quality medicines.

Pointing out some of the major challenges faced by the US when it comes to Indian pharma consignments, Sebelius who was accompanied by a select group of delegates including Deborah Autor, the deputy commissioner for global regulatory operations and policy, said that lack of proper security of supply chain which is leading to incursion of spurious products into the US is one of the major concerns along with data integrity that needs to be addressed urgently. She said that it is imperative for the Indian government and companies to address this issue at the earliest.

Clarifying this point, D G Shah, secretary general, IPA pointed out that misrepresentation and fraud is a very risky matter that most of the Indian companies would refrain from doing due to the heavy cost that they will have to pay for non-compliance. Shah added, “But most importantly it must be noted that an Indian company before entering the US market has passed through the rigorous standards of EMEA, MHRA, TGA, etc. and export to over 200 countries. Hence, they are under audit and inspection round the year, unlike the US generic companies, which is done by one or the other agency.”

Shah further informed that India’s direct exports of pharmaceuticals to the US has crossed $2 billion mark in 2009-10, accounting for one-fifth of the total exports of pharmaceuticals. India currently has more than 2,000 active DMFs-- the highest by any country in the world, including the US. He stated that IPA is working closely with the FDA to encourage capacity building among the companies and Indian regulatory agency.

However, taking a note on their problems Shah assured, “India has emerged as a major source of supply both for the APIs and the finished dosage forms for the patients in the US and the European companies supplying to the US market. Thus we have realised that it is in our interest to identify and prosecute black sheeps in the industry. We have therefore engaged a team of skilled investigators to trace and prosecute producers and distributors of counterfeit medicines.”

Sebelius also recognised the problems faced by the Indian companies due to multiple inspections and stressed on the need to build a coalition with the IPA for better understanding of the Indian pharma industry. Other major issued that were discussed included the IPR regime to serve national interest ,drug regulatory framework, balanced pricing regime etc.

Sebelius emphasised that for building confidence in the US on Indian made products it was essential for India to join the pharmaceutical Inspection Convention (PIC). However she pointed out that there is a need for regulatory harmonisation to facilitate entry of pharmaceutical products in different markets along with technical assistance programme for capacity building among the Indian regulatory authority and the industry. She also expressed her support and recognised the fact that India should to be on board of the ICH.