New paths to success
The first fortnight of November saw the Drug Controller General of India (DCGI) crack down on Mumbai-based Sun Pharma and GuruFcure based in Puducherry. While the DCGI asked Sun Pharma to stop all clinical research activity at its bio-analytical laboratory in Mumbai, GuruFcure was slammed for falsifying data in its applications for new fixed dose combinations. Sun Pharma is reportedly working to resolve the issue, citing an “ambiguity in guidelines” as the reason for this censure while there is no word yet on GuruFcure’s response to the DCGI order. The point is, India’s regulator seems to have realised that its own credibility was at stake if it did not crack the whip across the pharma value chain.
The two companies represent two very different, yet connected, facets of the Indian pharmaceutical industry. In terms of market cap, Sun Pharma is at the top of the heap while GuruFcure is one of many contract manufacturers. The latter may be much lower on the value chain but nevertheless lists quite a few of Sun Pharma’s peers as its clients. Abbott is the only MNC on the list and has since distanced itself from its former supplier as has Glenmark. Companies ranging from Alkem Laboratories, Hetero Drugs, Intas Pharma, JB Chemicals and the like are mentioned on GuruFcure’s client list on its website.
Pharma companies need to heed the warning as the crackdown is not likely to be a passing phase. The double whammy of increased spends on better manufacturing systems and lower growth will be a strain on balance sheets in the short term, but will hopefully fire the imaginations of pharma leaders.
To help companies navigate this complex labyrinth of regulations while coping with extremely tough market conditions, we asked experts for their insights on how companies can carve out new paths for success. As author Johnny Flora put it, ‘If necessity is the Mother of Invention, then adversity must surely be the Father of Re-invention.’
Thus the cover story of our CPhI India special section (API industry at crossroads: pages 50-63) has global experts give their take on what API manufacturers in India should do to become the No 1 API producer in the world. Similarly, the cover story in our PMec India section, (Robotricks: pages 70-74) advocates the use of robotics to improve quality and in the Indian pharma industry while the experts in the BioPh India section (New ways to grow: pages 174-177) look specifically at bio-betters and better regulation as the paths to success. We are sure that by this time next year, when Express Pharma will be in its 20th year, the Indian pharma industry will have bounced back higher and bigger than ever before.
Viveka Roychowdhury
Editor
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