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IPA Technical Seminar emphasises on quality metrics and WHO-GMP

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The seminar held in Indore was attended by around 100 delegates, managers, corporate heads and entrepreneurs

Due to economical cost of quality medicines manufactured in India, the US needs India more than India needs the US. This was stated by Ajit Singh, Chairman, ACG Worldwide, at the recently held IPA Technical Seminar in Indore. The event was organised by Indian Pharmaceutical Association, MP State Branch and Industry Pharmacy division and Department of Pharmaceuticals, Government of India. The conference was attended by 100 delegates, managers, corporate heads and entrepreneurs.

201704ep07The first day started of the seminar started over the theme, ‘Quality metrics- Future need of the pharmaceutical industry for marketing drug products in the US market.
Addressing the delegates, Singh mentioned about various needs of the pharma industry. He emphasised the need of quality pharma products at affordable price for lower / middle class population in India.

Shobhit Koshta, Deputy Drugs Controller, FDA MP and Rajneesh Choudhary, State Licensing Authority, FDA MP were present as the Guests of Honour.

Sanjay Kapadia, President Corporate Quality Assurance, IPCA Laboratories, opined about the importance of quality metrics as a tool to evaluate the pharma quality system. Sanjay Tiwari, VP, Sun Pharmaceuticals and Shantanu Chobhe, Associate Director, Abbott Healthcare at the conference emphasised on the importance of quality culture which needs to be included by Indian pharma units to survive and thrive in international markets. Vijay Kshirsagar, Director, TRAC Pharma Consulting, Mumbai spoke about data integrity as an overridding factor for quality metrics. Vipin Sharma talked about US FDA guidelines for elemental impurities in pharma product.

The seminar was conducted and moderated by Sanjay Sinha, President Formulation, IPCA Laboratories.

201704ep30Sanjay Jain, President IPA, MP State Branch, Anil Kharia, General Secretary, IPA MP State Branch and Dr SB Rijhwani, Vice President, Industry Pharmacy Division also took part in the seminar. The first day of the seminar was conducted by Dr Sapna Malviya, Shivanshu Kharia, Dr Narendra Vyas and Shruti Suraka.

The second day of the seminar had the theme, ‘Expectation of regulators from industries regarding WHO-GMP.’ Around 200 participants working in small scale industry, academia and students took part in the seminar.

Dr GN Singh, Drugs Controller General (India) (DCG(I), informed that drug prices are being monitored by PM Office. The guest of honour, Dr K Bangarurajan, Dy Drugs Controller (I),CDSCO, West Zone, informed that there is no shortage of stunt and the prices are monitored by government. He also talked about need of good laboratory practices and its complicate issues.

Koshta emphasised for better communication between the pharma industry and regulators for quality pharma products at affordable price. Rajneesh Choudhary, State Licensing Authority, FDA MP, wished the seminar a grand success. Brijesh Sharma, WHO Advisor, said that the government is working to accept the Indian Pharmacopoeia as book of standard as par with BP & USP by developing nations. Sanjeev Kumar, Dy Drugs Controller (I), Central Drugs Standard Control Organization Sub Zone, talked in details about the role of CDSCO.

Dr SB Rijhwani, VP IPA Industry Pharmacy Division said that if the industry has to survive, regulations and expectations of regulators need to be understood. Anil Khariya delivered the vote of thanks and Dr Sapna Malviya and Shivanshu Khariya conducted the seminar.

Kiran Petkar of Ujjwal Prabha Consultants emphasised about the validation in WHO certification. Amit Saxena (WHO consultant) and Bhart Doshi (Doshi Consultants) elaborated on market complaints and CAPA and up gradation of existing unit for WHO certification respectively.

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