Indian Pharmaceutical Alliance (IPA), a representative body of 20 research based pharmaceutical companies, has urged the government of India to join Pharmaceutical Inspection Co-operation Scheme (PIC/S) to enhance recognition of the country as provider of quality drugs and boost drug exports.
At present, 51 regulatory bodies from across the globe including US FDA, MHRA, PDMA are members of PIC/S. Over the last five years, IPA has been pursuing the government to join PIC/S.
The PIC/S is an instrument between countries and pharmaceutical inspection authorities to promote good manufacturing practices (GMP). The aim of PIC/S is global harmonization of health and regulatory inspection procedures by establishing common standards in the field of GMP and by providing training opportunities to inspectors. It also aims at facilitating co-operation and networking between competent authorities, regional and international organisations, to enhance mutual confidence.
The PIC/S membership offers a slew of benefits including reduced duplication of inspections, cost savings, export facilitation and enhanced market access.
The member countries of PICS import medicines from the manufacturing facilities of fellow member countries without duplication of inspections on the medicines and manufacturing facilities, helping exporters significantly save cost and time.
DG Shah, secretary general of IPA said “India, a leading generics player needs to step up efforts to join PIC/S. Today our growth and acceptance in the global market is limited because our drug regulator is not recognised as a member of PIC/S. If the quality of drug regulatory regime is enhanced, our ability to export and compete in the global market will go up significantly. It will help India maintain global standards and enhance global confidence in drugs coming from India.”
In order to become PIC/S member, India needs to become observer, then it can apply for membership. Its six-year long process. So far the government of India has not taken decision to become observer in PIC/S.
Dr GN Singh, DCGI said “Its a policy decision which government can take in consultation with the all stakeholders in the interest of patients.” Replying to a query, he said “As of now, we have not yet taken call on joining PIC/S as observer.”
When contacted to KL Sharma, joint secretary, Ministry of Health and Family Welfare said “We are studying the proposal to join PIC/S. The decision will be taken in this regard at appropriate time.”
The Indian drug regulator CDSCO is collaborating with global drug regulators in plant inspection. It helps Indian drug inspectors understand the expectations of global inspectors thereby helping pharma companies improve quality norms.
Over last one year Indian drug inspectors took part in 30 per cent of 150 US FDA inspections. “We are also planning to conduct joint inspection with MHRA, EDQM, EMA. We have entered quality management collaboration with MHRA. It will improve our drug inspectors and pharma industries' understanding of global standards and help them upgrade their quality norms,” said Dr GN Singh.
Currently CDSCO has a strength of 475 drug inspectors and state FDAs have a strength of 1300 drug inspectors. We have taken up capacity building programme wherein we are training state drug inspectors in good laboratory practices, GMP practices etc, he said.
Pankaj Patel, chairman & managing director of Zydus Cadila also emphasised the need for joining PIC/S to improve Indian drug regulatory system. “We are complying with PIC/S norms but there are a number of plants lacking PIC/S compliance. Its high time the regulatory authority ensures that all the plants in the country comply with global standards in the interest of patient safety,” he said.
Two-thirds of India’s exported drugs go to PICS member countries. With more and more countries seeking PIC/S compliance, it is need of the hour for India to join the forum to increase its drug export.
At present, small scale pharma industries which depend on domestic market are not willing to support India’s initiative to join PIC/S as it will force them to upgrade their manufacturing standards to meet global norms thereby putting financial burden on them.