Drugs Control General of India (DCGI) is yet to act on the repeated pleas made by the Indian pharmaceutical manufacturers regarding the presence of high chromium content in gelatin imported from China. They have intimated the regulator that the gelatin used for making empty capsules used for filling finished formulations are cheap but banned by the State FDA in China for human consumption.

In spite of this the union government has failed to take cognizance of this fact and such imports of continue which may seriously affect the patient population. According a team of medical experts, chromium is a toxic heavy metal and its intake would affect the skin, digestive system, even cause cancer and kidney failure.

India’s leading pharma grade gelatin manufacturers are  Sterling Biotech, Narmada Gelatin Limited, Nitta Gelatin to name a few. But in the last couple years, the cost of indigenous production of gelatin got escalated forcing many of Indian pharma companies to cut cost and started importing gelatin from China. But the Chinese gelatin found to be contaminated with chromium content in a higher percentage.

The pharma industry’s gelatin importers found that chromium contained in the gelatin was manufactured out of waste from the leather tanneries in China.  This is a critical situation because it is a  health hazard and would affect the patient population who are taking capsules, Sunil Mundra, managing director, Natural  Capsules told Pharmabiz.

 In fact,  Natural Capsules had personally intimated to the DCGI, Dr. GN Singh in a letter dated August 23,2013 via Reference no NCL/2013-14/955 and yet no action had been taken.

The cheaper gelatin with higher chromium content has been banned by SFDA, China because it is not for human consumption. Yet, this is being imported in India and used in various food and pharma applications. “We have requested the DCGI to prohibit imported gelatin because of its contamination,” he added.

In April 2014, Dr. Christopher Hickey, country director, People’s Republic of China, Food and Drug Administration issued a note to  the US-China Economic and Security Review Commission highlighting the challenges of globalisation and the drug regulator facing public health threats ensuing out of imports of China drugs. “It included heparin in 2007-08 and the presence of poisonous levels of diethylene glycol a product used in anti freeze. In 2012, China’s domestic supply chain, numerous companies used industrial grade gelatin containing more chromium than the edible gelatin firms should have used.”

In a face-to-face interaction with the DCGI, the Natural Capsules chief also informed him about the ban enforced in China by its State FDA. The union government has overlooked the quality of these products and continues to import the cheap and harmful gelatin from China.  Indian pharma is in a predicament, going by the dangers posed with its consumption, pointed out Mundra.