USFDA imposed import alerts on nearly a dozen Indian pharmaceutical manufacturers in the past couple of years over improper data integrity practices at their respective facilities. This was one of the deliberations among other relevant ones on how manufacturers can demonstrate the safety and efficacy of drugs with reference to data integrity along with creating awareness on various procedural issues and promoting the exports on the sidelines of a technical seminar organised by the Pharmaceutical Export Promotion Council of India (Pharmexcil) as a part of its 11th annual meet in Hyderabad in association with ministry of commerce under 'Pharma CEOs Conclave'.

As a part of the 11th annual meet, Phamaexcil had also organised the Global Pharma Business Meet. Global Pharma Business Meet was focused on API. The council with its continued tradition of organising a one-to one business meet invited around 85 international delegates from 30 countries. About 150 Indian pharma companies had B2B meetings and participated in the expo during the day and is expecting another 100 companies to participate in the next two days.

Data integrity implies ensuring products meet pre-established specifications, such as purity, potency, stability and sterility. In the absence of trustworthy data, these products cannot be trusted. As a result FDA has subjected many of these companies to import alerts, preventing entry of their products into the US. Since 2013, FDA has issued at least 10 Warning Letters to Indian companies alleging improper data controls. FDA has also sent several Form 483s, the precursor to most Warning Letters, to Indian companies such as one to Ranbaxy in January 2014. Data integrity issues strike at the very core of good regulation.

The technical seminar also deliberated on topics like financing in pharma industry and government schemes, clinical research and international practices, packaging of pharmaceuticals- protection and beyond, PIC/S and its implication on Indian pharma industry and exports, export opportunities on APIs, WHO prequalification programme for APIs, finished formulations and quality control laboratories.

The event witnessed the presence of Sudhanshu Pandey, joint secretary, department of commerce, government of India, Madan Mohan Reddy, vice-chairman, Pharmexcil, whole time director, Aurobindo Pharma and Dr P V Appaji, director general, Pharmexcil and dignitaries representing from the government and the pharma industry. The Pharma CEOs Conclave, based on the theme 'Present Global Challenges - Preparedness of Industry', was chaired by Satish Reddy, chairman – Dr. Reddy’s Laboratories with panelists being Rajiv Nannapneni, vice-chairman and chief executive officer, Natco Pharma Ltd., Debasish Mallick, deputy managing director, Exim Bank, Dr. Sivakumaran, director – Aurobinda Pharma Ltd., Dr. Akun Sabharwal, IPS, director general, Drugs Control Administration – Telangana, Dr. Ravi Shankar, IPS, director general, Drugs Control Administration, Andhra Pradesh. Sudhanshu Pandey was the chief guest for the conclave.

Pharmexcil distributes export and patent awards for over last eleven years, in its endeavour to promote exports and facilitating member companies at its best. The council has continued to provide support to its member companies in promoting their exports globally. In recognition of its member companies tireless efforts and to further encourage their achievements. Dr Gokaraju Gangaraju, Member of Parliament presented awards to the national winners in pharma exports and pharma patents.