The two-day long IDMA -APA PAC 2015 conference on ‘Quality and Compliance – Global Expectations’ in Mumbai sought to enlighten the attendees with detailed information on the regulatory requirements for marketing pharmaceutical products
Usha Sharma – Mumbai
Indian Drug Manufacturers’ Association (IDMA) recently organised the 18th edition of the Pharmaceutical Analysts’ Convention in Mumbai. The two-day long IDMA -APA PAC 2015 conference on ‘Quality and Compliance – Global Expectations’ in Mumbai sought to enlighten the attendees with detailed information on the regulatory requirements for marketing pharmaceutical products in the global pharma market and the parameters to meet compliance issues.
Dr K Bangarurajan, Deputy Drugs Controller (India), CDSCO, West Zone Mumbai shared insights on the initiatives taken by the CDSCO. He informed about the last assessment process conducted by the WHO -Geneva which took place in 2012, spoke about the challenges faced by the Indian regulatory authority and recommended steps to overcome them. He also informed that the next assessment is going to take place in early 2016 by the WHO team.
The CDSCO has tied up with the WHO and many other agencies to initiate different regulatory programmes which would help in meeting the global standards. Bangarurajan also spoke on equipping the Indian regulators as well as technologies to meet global standards. He also mentioned that under the five year plan, the government has sanctioned Rs 1000 crores for setting up state and central laboratories as well as strengthening manpower across India.
Commenting on the regulatory parameters being followed by the Indian pharma companies, he said that out of the total exports, nearly 48 per cent medicines are exported to the regulated market which shows that our regulations are at par with the global standards. He also added that the CDSCO has already started online initiatives and now companies can apply online for export application.
Subhanu Saxena, Managing Director and Global Chief Executive Officer, Cipla was the chief guest of the conference and he delivered a speech which was inspiring and well appreciated by the audience. While delivering the speech he mentioned, “Our mission is to deliver high quality medicines at affordable prices to both Indians as well as global patients. He also added that hence we should set our own standards for safety measures. Further, highlighting the importance of investing in existing resources, he said that our people are the biggest assets of an organisation because they are well disciplined, organised and committed than anybody else in the globe, so we should invest in them.” He further said, “We want to equip them to handle critical challenges and help them in striking better perspectives.”
Saxena also stressed that partnerships help organisations to grow much faster. He suggested that we should have active partnerships with regulators, which will help in exchanging and broadening ours as well as their perspectives. Signing off, Saxena said that we should work with compassion, passion and commitment.
Dr PL Sahu, Principal Scientific Officer, Indian Pharmacopoeia Commission shared details of the initiatives introduced by Indian Pharmacopoeia, for e.g. SMS alert facility.
Dr KV Surendranath, Senior Vice President, International Site Operations, United States Pharmacopoeia revealed USP’s strategies for the next five years. He also mentioned that USP’s strategies were introduced last year and over the next one and a half years, they would be evaluated continuously. Surendranath informed that they are investing largely in research and development to support the mission of creating food for the database. He also revealed that they were going to work on modernising of monographs. “USP’s new way of working is reinforcing the criticality of science and quality,” he said.
SM Mudda, Chairman, Regulatory Affairs Subcommittee, IDMA presented the US FDA draft guidance on how FDA intends to use quality-metric parameters. He also mentioned about the effects of non-reporting and its impact on a pharma company’s performance.
SG Belapure, President, Manufacturing Formulations, Zydus Cadila talked about validations in the pharma industry. He pointed out that in the earlier days, validation used to be a one time exercise, whereas these days it is more like a life-cycle approach. He also informed the audience that the new Annexure 15 EMA qualification and validation guidance is becoming effective from mid-October, this year.
The organiser also presented ‘Young Analyst of the Year’ and ‘Outstanding Analyst’ awards to Dr Manesh Jagtap, Manager, Regulatory Affairs, JB Chemicals and Pharmaceuticals and Dr Premnath Shenoy, Chief Technical Officer, Dossier Solutions & Services respectively.
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