JOIN USWait for TB vaccine continues
In a curious turn of events, their discovery —once hailed as a prime achievement for Indian science—may not hit the market soon despite obtaining regulatory approval after seven long years.
It began two decades ago when a group of Jammu scientists discovered a unique property of piperine, the key ingredient in black pepper and long pepper. It was the first original Indian scientific achievement with an indirect clue from ayurveda. They found piperine acted as a bio-enhancer and reduced the dosage of rifampicin, a common TB medicine.
If the regular rifampicin dosage for a TB patient is 400 gm, the patient would require only 200 gm if the medicine is consumed with piperine.
The bio-enhancer increases the medicine’s availability inside the body thereby reducing the effective dosage.
Clinical trials began in 1991 at the Indian Institute of Integrative Medicine—formerly known as Regional Research Laboratory, Jammu—in collaboration with few hospitals, including the SDS Sanatorium in Bangalore. The technology was transferred to Cadila in 1993. All trials were completed by 1999 and within two years all relevant data was submitted to the Drugs Controller General of India (DCGI) seeking permission for commercial launch.
‘No progress’
Scientists said there was virtually no progress since 2001 when the top brass of the Council of Scientific and Industrial Research (CSIR)—the parent body of IIIM—and Indian Council of Medical Research asked DCGI on its progress. The DCGI carried out an independent evaluation and found the bio-enhancers satisfactory. But it still sat on the application for the next seven years. “What can we say about the delay. DCGI is the regulator, which decides. There are processes within process and at the end one may or may not get the approval,” said a top Cadila official on the condition of anonymity.
Fortunately for the Ahmedabad-based drug company, the DCGI permission for two formulations came in December, 2008. The company was to launch the rifampicin-piperine combination product under the brand name of Resorin on March 28, sources told Deccan Herald. But the launch was deferred after the company shifted their attention to a different product. Cadila top management said that piperine is not the priority product as the firm was “working overtime” on a poly-pill against heart and stroke.
“The polypill is expected within a few months. The piperine will be launched later,” said Rajiv Modi, managing director of the company.
This means more agonising wait for the scientists, who are putting up a brave face. “Science was ours. But it’s a commercial decision which Cadila has to take,” said IIIM scientist R K Johri who was working on piperine for two decades.