The Good Manufacturing Practices (GMP) norms which should take effect in two months time from now is not an attempt to burden the industry with more regulations, but is the first step meant for guiding the drug industry towards self regulation and self auditing of quality compliance, Ashwini Kumar, Drugs Controller General of India (DCGI) has said.
"GMP cannot be imposed, it has to be a commitment from within the industry. The concept of self-auditing is being introduced to the industry for the first time now. It is for the industry to change their mindset and adopt stricter benchmarks of quality", he said.
Addressing a seminar on "GMP - Selected Elements" organized by Indian Pharmacy Graduates' Association (IPGA) on November 1, 2003 here, the DCGI pointed out the dichotomy between the two sections of Indian drug industry. "Indian drug industry is internationally recognized as the one with most growth potential. However, we have, on one hand, companies who follow international quality benchmarks and looking out to capture global markets and on the other, companies who still lack fundamental requirements. Uniform compliance of GMP norms is the biggest challenge before the regulatory agencies. There cannot be two sets of rules"
DCGI wanted the industry to give a serious thought to this issue. "It's going to be two years since the revised Schedule M was announced. The industry should review the changes they have made during this period. Let them give us a feed back on the issues, which are preventing them from implementing the new requirements. The department is willing to review any regulations that are posing any genuine trouble to the industry", he assured.
He reminded the industry representatives attending the seminar that GMP compliance is more a problem of mindset than financial commitment. "Let us understand that GMPs are here to change the whole approach towards quality assurance," he said.
Dr B Suresh, President, Pharmacy Council of India (PCI) in his address highlighted the need for tailor made high-end educational programmes in pharmacy to meet the increasing regulatory requirements. Dr Suresh was the guest of honour at the inaugural session of the one-day seminar.
The seminar had delegates from the drug industries in and around Delhi. The topics covered during the technical sessions were site master file and its importance, consideration for plant layout and design, validation / process validation and its proper implementation, air handling unit and its utilization in the pharmaceutical formulations and implementation of revised schedule M by SSI. The faculty included Dr S K Khanna, executive director, Oscar Group, New Delhi, P.P. Sharma, Delhi Drugs Control Department, M Mitra, CDSCO (North Zone), Varun Mehandru, M D, Alfatech Aircon Pvt Ltd and Dr D Roy, CDSCO (North Zone).
The dignitaries who were part of the programme include P.P. Sharma, President IPGA, Prof K Chinnaswamy, General Secretary, Indian Pharmaceutical Congress Association (IPCA), A Krishna Dev, Treasurer IPCA, Ravi Uday Bhaskar, President, All India Drugs Control Officers Confederation (AIDCOC), Atul K Nasa, secretary IPGA and S L Nasa, secretary, Indian Hospital Pharmacists Association (IPHA) among others.