Vizag Pharma Summit deliberates on the future of Brand India Pharma

The theme of the maiden Vizag Pharna Summit was Shaping the future of Brand India Pharma

Usha Sharma — Vizag

After the successful inaugural editions of Sikkim and Goa Pharma Summit, Express Pharma recently organised the Vizag Pharma Summit. The theme of the maiden Vizag Pharma Summit was ‘Shaping the future of Brand India Pharma’. The day-long event was attended by over 80 delegates which included representatives from formulation development, research and development, QA& QC, regulatory affairs, packaging, plant head, supply chain management purchase and decision makers.

During the event, experts of pharma industry touched upon critical topics like strategies to achieve full compliance, measures to achieve self-sufficiency in APIs, linking talent to value, embracing digital and automation to build next-age capabilities, deploying global best practices, enabling a culture of quality at the shop-floor and sustaining cost-leadership with product
excellence.

The event began with the lamp lighting ceremony by T Ravi Kumar, Joint Drug Director General, Drug Control Administration, Government of Andhra Pradesh, who was also the chief guest of the event. He was joined by R Srinivasan, ADC, CDSCO-Vizag Port Office and Srinivas Lanka, Senior Advisor, Pharmexcil.

In his Chief Guest address, Ravi Kumar talked about adoption of technologies to address quality concerns in pharma SMEs. And said that technology adoption is an investment and not an expenditure. He also mentioned about the initiatives been taken by the state government to encourage pharma industry to enhance their performance in the global pharma market. He also stressed on building common effluent treatment plants for small and medium-sized pharma companies, which will assist financially and help them in upgrading to the next level. During his presentation, he also informed about the advantages the state offers to the pharma industry.

The next speaker at Vizag Pharma Summit, Ramanuj Samal, Application Specialist, Beckman Coulter Life Sciences elaborated on the topic of improved compliance, reduced workload and cost with Anatel Online TOC Analysis of pharma waters. He explained the importance of purified water in the pharma segment and mentioned that for pharma use, it is classified as an excipient in the production of non-parenteral preparations, and in specific, for pharma preparations/tests and assays, in which water is indicated, unless otherwise specified. His presentation also touched upon the product portfolio which Beckman Coulter Life Sciences offers in the Indian market.

Anvesh Manne, Director, Polmon Instruments, provided a brief summary of the company’s ongoing activities. He delivered a talk on distributed temperature control of laboratory scale reactors. He talked about solutions which the company offers like maximum utilisation of lab space, eliminates clutter in the lab, centralised control and data logging, recipe management, local graphical HMI on the fume hood etc.

The next presenter of the day was Vaibhav Datke, Senior Manager, Business Development, Ami Polymer. Datke gave a presentation on polymer solutions to the pharma industry.

He also informed about the company’s global distribution channels, product profile and mentioned about pharma tubings in drug processing applications and its key components. He highlighted that all liquid drugs in glass vials are passed through silicone tubing for precise filling and those tubings are used once in a day per batch and it is replaced for every new batch. He also explained how Ami Polymer’s products are helping pharma companies impart good solvent resistance and multiple varieties of tubings which have been designed.

Dr Kavita Vengurlekar, Product Manager Data Sciences Group, Caliber Technologies presented on the future of pharma-quality metrics and data analytics. In her presentation, she highlighted the importance of quality metrics and FDA’s 21st century vision for pharma engineering. She mentioned that quality metrics are not new to the life sciences industry and are already being used; to continuously monitor quality systems and processes (cGMP), provide information on where improvements can be made, as a part of the annual product review (APQR), as a part of internal audits and to evaluate supplier qualifications. While informing about the modified proposal from FDA on quality metrics she said that the industry should start with three metrics; lot acceptance rate (report by site, differentiated by product), product quality complaints (report by product only) and invalidated OOS (report by site). She also pointed out how artificial intelligence will drive the decision-making process.

The next speaker was Srinivas Lanka, Senior Advisor, Pharmexcil, who talked about steps to minimise India’s APIs dependency and increase pharma exports. He said, “Vizag coast has a great strategic advantage to become the health capital of the globe. A mega cluster of eight clusters — API, dosage formulations, biotechnology, fermentation, nanotechnology, herbals/traditional medicine, medical technologies, research linked to MedCity is feasible and will free India from unnecessary import dependence. Universities, scientific talent, social harmony is conducive for rapid growth which will have the potential to generate revenues of over Rs 50000 crores each year.”

This was followed by a panel discussion on transforming Vizag into a pharma centre of excellence. The session was moderated by Lanka from Pharmexcil and were joined by Dr Girish Dixit, Senior Vice President and Head CMC, Pharmaceutical Science and Technology, Eisai Pharmaceuticals, India, Suresh Kamath, Vice President Operations, Natco Pharma and KVV Raju, CEO, Granules OmniChem as panelists.

Discussions were held on API import reduction and type of financial reforms needed for the industry to take up import substitution. Panelists spoke on how industry can reduce operational costs for individual units through shared services andcompete with China with respect to operation costs.

Dixit from Eisai Pharmaceuticals said, “There is no difference in the chemistry skill sets of China and India, only mindset differs. Institutes should get into  research for commercial requirements and support industry to overcome innovation challenges. Adoption of new technologies like flow or continuous manufacturing, biocatalysts, enzymatic reactions are need of the day. This can be achieved by creating ‘synthesis and solid state cluster’ in Vizag. By this, we can make Vizag a centre of excellence.”

Kamath from Natco Pharma felt the urge of pharma knowledge sharing platform in Vizag, highlighting the number of pharma units located in the city. He mentioned that there are very limited interaction between industry and regulators.

Raju from Granules OmniChem informed about Sagarmala project which is initiated by the government to enhance the performance of the country’s logistics sector. Vizag being the hub of pharma manufacturing units, pharma industry can optimise the opportunities, is what he mentioned.

Next, R Srinivasan, ADC, CDSCO-Vizag Port Office spoke on bolstering pharma exports via sea port. Samal from Beckman Coulter Life Sciences gave another technical rich presentation on hight resolution nano and micron particle characterisation – pharma development to production.

Following his presentation, Prabhas Misra, MD, PSA Nitrogen, highlighted the relevance and importance of nitrogen gas in the pharma industry. In his talk, he said that nitrogen being an inert gas is extensively used in the pharma industry to avoid possibility for fire or explosion. “Usage of nitrogen gas for blanketing purpose in pharma industry for various applications has increased substantially during the last one decade and is likely to increase further in the coming years. We have supplied more than 1400  PSA Nitrogen Plants in the pharma sector alone during the last 35 years,” Misra added. He also informed that his company has captured 90 per cent of the business market in India. He talked about the technical collaboration with Kuraray Chemical Co – Japan, and mentioned that the products are supplied in over 20 countries.

Nisha Chowta, Sales Manager, Gandhi Automation, in her speech pointed out the need for pharma warehouse and logistics automation. In her presentation, she gave an overview of the company and how her company’s solutions can work as high-performance cleanroom doors with easily disinfected surfaces and meet the most stringent hygienic requirements.

Akash Agarwal, CEO, Director, Crystal Logistic Cool Chain, gave a presentation on the solutions which the company is offering for cold storage. He informed about the company’s offering in five brands globally, which has rented/sold more than 12000 units of containers worldwide.

The next speaker at the summit was Satyaprasad Venkata, Managing Director, Smart Labtech. In his presentation, he talked about the industrial weighing solutions. He gave a brief description about the company’s product portfolio. Highlighting the relevance of weighing solutions in a laboratory, he said that it is important to test pharma products and their ingredients.

Chidanand BN, National Head Sales & Marketing, Markem- Imaje India, spoke about choosing the right coding solution. His presentation gave an update about different coding technologies which Markem- Imaje India offers in India. He also expressed that his company has capabilities to meet the industry’s requirements.

Shantanu Panda, Deputy General Manager, Global Packaging Strategy, Mylan Laboratories, delivered a talk on innovation in pharma packaging – A way forward. He said that in the whole cycle starting from product-pack development to usage by end-user, each design, action and process is gettng digitalised with respective electronic platforms and they are also being integrated for better accountability and coordination. Serialisation, 2D code, QR Code, Mobile authentication are a few of them. Digitalisation will help for easy accessibility /storage / usage of data, which will be more compliant and reliable.

Later on, he joined a panel discussion on ‘Strategising for a tech-driven future’, which was moderated by Madan Mohan Reddy, Head – India Regional Quality & Regulatory, Eisai Pharmaceuticals. The panelists were Bikash Kumar Nayak, Plant Head, Aurobindo Pharma, Dr Sreeram, Plant Head & Director, Shilpa Medicare and Narendira Kumar, Site Quality Head (QA & QC), Dr Reddy’s Laboratories.

The panel discussion touched upon different challenges faced by pharma companies in fulfilling requirements from various regulatory agencies e.g. DGFT (India), serialization (US FDA & EU). Discussions were held on regulatory expectations, dependency on automation, which  may lead to some failures, measures for anti-counterfeits. In the beginning of the discussion, Reddy said that patient-centric drug development is the key to future.

Panda cautioned that those who change and adapt will progress and those who  resist, will be forgotten. Responding to the moderator’s queries, he said that the pharma packaging industry is going through a phase of change towards end-to-end digitalisation and optimisation. Pharma packaging is facing pressure, on reduction in profit margin and growing competition in the generic drug market. Optimisation is key to succeed in this race. So, the focus will be to optimise the packaging design, material and process to make it more cost effective. The rule is to “Increase the convenience”, “Cut the excess” and “Stick with compulsory”. He also highlighted that the future smart packaging will be more “Optimized-Connected-Compliant-Patient Centric.”

Commenting on the regulatory aspects, Kumar pointed out, “Automated solutions in the manufacturing environment (including laboratory) will give more confidence to the regulatory inspectors about management’s commitment on GMP compliance and continual improvement.”

Sreeram talked about the importance of critical process parameters under the QbD. He said, “I am sure that in next five years, the US FDA will come heavily on pharma R&D centres where the product development takes place. The time has come (if not already late) for the pharma companies to move towards paperless documentation and data-driven product development using the tools such as QbD and PAT. This will bring more transparency, accountability and credibility to product development work.”

Highlighting that AI will play in the future, Nayak said that the future of Indian pharma industry is completely based on data integrity and automation is going to play a major role in shaping the future of Brand India Pharma.

The participants of the Vizag Pharma Summit lauded Express Pharma for creating such a platform and mentioned that it will help the industry in understanding the problems and suggesting solutions.

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