The Sweet Pill

Drug regulatory reforms in China have turned the heat on the Indian pharmaceutical industry and raised the cost of bulk drugs. But some firms have managed to turn the crisis into an opportunity by filling in the space left by the Chinese.

- E. Kumar Sharma

Ludhiana-based IOL Chemical, the largest maker of ibuprofen active pharmaceutical ingredient (API) in the world with annual capacity of 12,000 metric tonnes, is in a sweet spot, a rarity these days in a segment such as API manufacturing, where China has taken a lead over India. “We are noticing shortage of products from China and rise in prices. This is a big opportunity for the companies in India to build global capacity to take advantage of the trend. For instance, we have – over the past one year – more than doubled our ibuprofen API capacity from 5,000 metric tonnes per annum to 12,000 metric tonnes,” says Vijay Garg, Joint Managing Director, IOL. The company has “33 per cent world market share for the product as against 10 per cent a year ago,” he says.

The reasons lie thousands of miles away in problems that the API or bulk drug industry – which provides key ingredients for tablets – is facing in China. Around mid-2017, China’s Food and Drug Administration joined the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) as a member. China also became a member of the Geneva-based Pharmaceutical Inspection Convention (PIC). The steps required the Chinese regulator to become more stringent. This resulted in shutdown of massive capacities in China, for years a big supplier of bulk drugs globally. Though this has led to a rise in prices of bulk drugs – a key input for pharmaceutical companies – some Indian bulk drug makers like IOL are trying to fill the gap left by the Chinese. “This could be a blessing in disguise for the Indian API industry,” says D.G. Shah, a veteran in the Indian pharma industry. The former director-general of Indian Pharmaceutical Alliance had shared this and other insights with Business Today just before his sudden death in February this year.