CDSCO likely to set up CDTL in Indore
Usha Sharma – Indore
Indian Pharmaceutical Association (IPA) (MP State Branch) and PharmaTech recently organised a three – day seminar and exhibition, Pharma Tech Expo 2015 at Brilliant Convention Centre in Indore. Speakers addressed various regulatory requirements of India as well as regulated markets.
Ramesh Agrawal, President, Federation of Madhya Pradesh Chambers of Commerce and Industry (FMPCCI), the Chief Guest of the event, while speaking at the inaugural session of the seminar, encouraged the investors to invest in Madhya Pradesh. He also mentioned that the state has adopted online application methods for conducting most of the government activities.
Dr K Bangarurajan, Deputy Drugs Controller (India), Central Drugs Standard Control Organization (CDSCO), West Zone Mumbai, who was present on the first day said that the Indian pharma industry has the potential to deliver quality medicines to the world, but fails to maintain data documentation. He also informed, “Presently, Indian pharma companies manufactures Rs two lakh crore worth of medicines and export to nearly 214 countries. Also, India largely exports to the US market which is highly regulated.”
Bangarurajan emphasised the fact that the pharma industry plays an important role in attracting foreign investements to the Indian market and the government is serious and very enthusiastic under the 12th Five Year Plan. The government has sanctioned an amount of Rs 1700 crores for strengthening CDSCO of which Rs 1000 crores would be invested in setting up a Central Drugs Testing Laboratory (CDTL) and strengthening manpower.
Bangarurajan announced that CDSCO has planned to set up a CDTL in Indore, for which the construction work is likely to be commissioned early next year. He also mentioned that CDSCO will have offices in all the states which will help streamline the regulations. He also stressed on the need to comply with good manufacturing practices.
While delivering a lecture on WHO GMP Certification – Regulator’s Expectation, Bangarurajan presented a list of expectations and procedures, which the Indian pharma companies need to follow in order to pursue an application. He also spoke about WHO-GMP procedures and its importance in exports and data integrity problems.
Dr RS Rijhwani, Chairman of Industrial Division, IPA, welcomed the delegates and said, “The prime focus of the show is to uplift the pharmacy profession in India and we will work in line with the Prime Minister’s vision of ‘Make in India’campaign. He said, “Seeing the growth rate of pharma exports, we have a lot of potential to grow. To avoid any regulatory issues, we need to channelise things properly.”
Dr Subhas C Mandal, Directorate of Drugs Control, Government of West Bengal and Vice President Chairman, IPA – Regulatory Affairs Division, spoke about the relevance of the seminar in today’s scenario. He said, “We used to talk about technologies and innovations but now we see more discussion on pharma production.”
Dr Rao VSV Vadlamudi, President, Indian Pharmaceutical Association said that Indian pharma companies which are manufacturing and marketing drugs for the global pharma market need to work aggressively towards providing quality medicines. With the help of pharma professionals, IPA can provide quality healthcare which will help in reducing mortality and disease burden.
Dr Maharukh Rustomjee, Consultant – Life Science and Healthcare and Founder Director, Rubicon Research, gave a glimpse of the regulatory developments since the last 15-20 years which have led to a continuous shift in the quality paradigm.
Abha Pant, President -R&D (Formulations) IPCA Laboratories talked about the expectations of regulatory agencies. She stressed on to minimise the difference of the western world and the Indian market. She also pointed out that apart from solid dosage drugs form, biologic, transderma etc will soon be off patent. Moving on, she raises the query that if Indian pharma companies are finding it difficult to produce documents for solid dosages then how are we going to tap forthcoming business opportunities?
She also highlighted the challenges that the Indian pharma companies are facing, where both Indian states as well as central authorities are issuing approvals whereas in other markets, a single authority has been deputed. “Besides these, there are a number of divisions and sub-divisions under our ministry, which I feel should become one authority,” suggested Pant. She also pointed out that today a number of approvals are needed before conducting research and development, which is a time consuming process. Signing off, Pant said that the industry should become a member of International Generic Drug Regulators Pilot (IGDRP).
On the second day of the seminar, Sanjay Tiwari, Director – Pharma Manufacturing, Sun Pharmaceutical, significantly mentioned that India and China stand top of the list of the US FDA’s 483 list. He also highlighted that data integrity is the key reason why most of 483s are given to pharma companies. Moving forward, he suggested that there is a need to have periodic inspections to avoid such problems.
Amit Saxena, General Manager – Corporate Quality Project Manager, Sun Pharmaceuticals said that internal audit is important during laboratory operations.
Dr Subhas Pande, Senior Vice President, Corporate Quality Assurance, Cadila Healthcare conveyed the message to the audience that there is nothing to worry about the US FDA observations and companies can follow compliance procedures.
On the last day of the seminar, the DOTS-TB Training Programme was held. A day-long session was organised for retail chemists on how to eradicate TB cases in India. The programme was attended by nearly 50 chemists, where they were educated on how to create awareness about the disease and also about the government’s initiative to offer free medicines to the patients.
Manjiri Gharat, Vice President Chairperson, IPA -Community Pharmacy Division, DOTS TB Pharmacist Project Leader briefed about the programme and mission of the agenda to all retail chemists.
Dr Atul Kharate, MP State TB Officer, Joint Director Health Service, informed about the current status of TB cases and initiatives being taken by the state government. While sharing details, he said that presently there are only six Cartridge-Based Nucleic Acid Amplification Test (CBNAAT) TB detection machines available and in next two months the state will get 70 new machines. Presently, the tests cost Rs 2000 each at private institutions while it will be done free of cost at the DOTS centre
Dr Vijay Chhajlani, District TB Officer, Indore requested all the chemists to report TB cases and help the state government in identifying the cases and improve the health of TB patients in Indore. He also urged pharmacists to not dispense phenoline medicine to random patients, as they are to be dispensed based on prescription. He aims to see Indore TB-free by 2020.
Ramesh Shah, Managing Director, Pharma Technology Index thanked the exhibitors and visitors for making the event a successful one.
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