Initial skepticism has given way to healthy collaboration with some of the top drugmakers in the country coming together to up quality standards not just in their companies, but for the larger pharmaceutical industry.

The vision on setting a global benchmark on quality is not an optional one, said Lupin Managing Director Nilesh Gupta, speaking candidly on the need for a “quality transformation exercise” in every organisation. Gupta's message was echoed by a stellar panel of top honchos from Dr Reddy's Laboratories, Sun Pharmaceuticals, Zydus Cadila and Cipla, participating in the grand finale of a two-day quality conference. Their deliberations assume significance, given the regulatory action on some of the biggest names in the industry including Sun, Wockhardt and DRL in foreign markets.

Companies undergo about a dozen regulatory inspections in a year and Lupin prided itself on its clean record till it received nine regulatory observations from the US regulator, said Gupta, adding that it was a “wake up call” that saw the company bring in more rigour and discipline in its quality systems. Things will go wrong, he said, adding that the challenge was in tackling it and doing what it takes to resolve it. He also stressed the need to bring in more technology into their quality systems.

Dr Reddy's Laboratories' Chairman Satish Reddy pointed out that quality systems in the company were resulting in incidents being picked up by employees before it flared up into a major issue. The challenge he said was in trying to “retrofit” new procedures and equipment into traditionally old plants, an expensive and not always fruitful exercise.

The benefit from such a quality collaboration, said Cipla's Managing Director and Chief Executive Umang Vohra, was the birth of an ecosystem that upped the industry benchmark. Something that was critical since companies hired from each other.

Industry leaders also stressed the need to train people in the indsutry, even as they create a pool of “industry-ready” people who could be hired. Zydus Cadila Chairman and Managing Director Pankaj Patel outlined the “Quest” programme in his company that focussed on training, including initiatives where workers training workers. The challenge was in keeping employees motivated, he said.

Sun Pharma's Managing Director Dilip Shanghvi said that working with industry counterparts had helped cut short the learning period for the company, after it acquired Ranbaxy and became twice its size. The learning on managing technology, integration, root cause analysis on quality issues and its resolution was fast tracked, he said, as industry representatives worked together on common ogranisational policies on similar issues. As a result they have common quality standards across their manufacturing plants to be able to make comparisons etc, he said. What is about a year behind schedule though, he added, was the initiative to go paperless.

Organised by the Indian Pharmaceutical Alliance, the quality conclave saw the participation of regulatory representatives from the United States Food and Drug Administration, the United Kingdom's MHRA and France's EDQM.