The International Pharmaceutical Excipients Council of India (IPEC) is poised to play a greater role in IPEC international activities and assist the government of India in evolving the direction, standards and development of the excipient industry in India, according to Ajit Singh, chairman of ACG Worldwide and founder & chairman of IPEC.

Talking to Pharmabiz recently, he said the future plans of IPEC India are to further build up the organization, particularly the managing committee and the board, with persons of repute, knowledge, commitment and passion. IPEC India calendar is full of activities to promote the healthy growth of the excipient industry in India and spread knowledge and training in this largely neglected area, he added.

One of the early activities of IPEC India was to attract suitable members drawn from Indian companies as well as importers and distributors of excipients and also to give membership to appropriate members of the government, academia, technical experts and the like.

Another activity had been to set up a board and a managing committee. Its members meet regularly and sub-committees have been formed in various areas of activity viz. regulatory, GMP & compendial review, membership, communication & PR, etc.

Conferences and study groups were regularly held and have attracted large audiences and excellent speakers from overseas and India.

A number of representations to the government to assist in formulating regulations and measures to assist the industry are underway. Several members from the Managing Committee and Board have attended international IPEC meetings for eg. Annual Meeting in Nice, France and their learnings are reported to the members.

According to him globally much more attention is now paid by regulators to excipients and their impact on quality and patient safety.

Many global excipient manufacturers refer the voluntary IPEC-PQG Good Manufacturing Practices and IPEC Good Distribution Practices guides to manufacture their own products. IPEC India is advocating the use of these guidelines to our membership.

EXCIPACT and ANSI are other non-government private organizations that can provide GMP certifications to excipient manufacturers based upon successful audits conducted by authorized bodies. The regulatory environment is continuously changing and for example a “legal” requirement and directive for excipients putting the onus of excipient quality on the drug product manufacturer is the EU Falsified Medicines Directive (Directive 2011/62/EU). As a consequence of this, guidelines were issued by the European Commission (2015/C 95/02) which came into force since March 2016. The guidelines require the marketing authorization holder to assure that formulated risk assessment to determine appropriate good manufacturing practice for excipients.

Dwelling on the excipients industry in India, he said it is small for a large country like India and a leading global pharmaceutical generic supplier. The supply of excipients is mostly in the hands of importers and traders. However, most of them are knowledgeable and well trained by their principals abroad. They also provide stocking and supply in credit and good service to the pharma industry. The manufacturing activity for excipients in India is slowly growing.

There is a need for new excipients to increase options for the formulation and delivery of the newer molecules coming through the development pipelines, he said.

IPEC has called on the FDA-India and Indian Pharmacopoeia Commission (IPC) to establish a new regulatory review process for excipients in order to bring more novel excipients into the market and facilitate the growth of the industry. However, it would be welcome if our Government collaborates internationally to establish globally harmonized standards and practices for excipient supply. This is in the best interest of quality of excipients and patient safety, he pointed out.