Biological drug testing centre gathers dust

Biological drug testing centre gathers dust
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First Published: Sat, Feb 02 2008. 12 38 AM IST

Limited usage: The enzyme and hormone testing lab. The government has spent Rs237 crore on the institute since it was set up in 1992. (Photo: Ramesh Pathania/Mint)
Limited usage: The enzyme and hormone testing lab. The government has spent Rs237 crore on the institute since it was set up in 1992. (Photo: Ramesh Pathania/Mint)
Updated: Sat, Feb 02 2008. 12 38 AM IST
New Delhi/Bangalore: The National Institute of Biologicals (NIB) is spread across a futuristic 18 acres in Delhi satellite Noida. The world-class laboratories here cost Rs114 crore; the facility has automated cage washers, the country’s first such, for inmates of 40 animal houses; and the campus has three 2.5MW generators, which can supply power to almost all of Noida.
Limited usage: The enzyme and hormone testing lab. The government has spent Rs237 crore on the institute since it was set up in 1992. (Photo: Ramesh Pathania/Mint)
There’s only one problem: the facility isn’t being used.
NIB was visualized as an independent authority that can test and authorize the marketing of biological products or biologicals—medicines drived from living systems—not just in India but across the Asia-Pacific region.
Today, the facility tests barely 15 products a year. Its animal cages are empty. And it is staffed by nine scientists and around 13 technicians although it has a sanctioned strength of 85 scientists and 115 technicians.
NIB was set up under the ministry of health and family welfare in 1992, a time when the biologicals wave was just beginning here. Since then, the government has spent Rs237 crore on the facility. There are around 350 biological drugs in the market today, and it is unclear how many of these have been tested, and where.
However, despite the law—the Indian Drugs and Cosmetics Act—mandating NIB as the apex agency for testing biological products, it is anything but that.
“It’s an investment that is totally unutilized. I have no excuse to offer because as health secretary I was responsible for it for some years,” said Prasanna Hota, India’s former health secretary who laid down office in October 2006. “It’s an albatross that hangs around my neck,” added Hota.
Apportioning blame
Empty spaces: Animal cage meant to house primates before they are used in research lie unoccupied. (Photo: Ramesh Pathania/Mint)
Hota said he is willing to take the majority, or 51%, of the blame for NIB’s sorry state. According to him, “Former Indian Council of Medical Research (ICMR) director general N.K. Ganguly should share 30% of the blame.”
Ganguly was acting director of NIB for eight years, and some of the staff at the institute recollect that his visits to it were restricted to once a year.
In a foundation day lecture at NIB on Tueday, Ganguly claimed that NIB’s laboratories were actually completed last year, and that it could take another 10 years for the facilities to be optimally utilized. “It’s true that the Rs65 crore budget extended to Rs300 crore. But now is the time to accredit the labs and make it functional,” he added. While the last section of NIB was completed in 2007, staff at the institute say laboratories were completed and handed over to them starting 2000.
And Ganguly’s defence still does not explain why the institute is operating with nine scientists and 13 technicians. NIB’s current director, V.K. Kashyap, who took over from Ganguly in April 2005, declined to comment on the issue, and would only say that the proposals for recruitment, as with several other schemes, are pending with the health ministry. Union health secretary and chairman of NIB, Naresh Dayal, who has not visited the institute even once after assuming office in October 2006, could not be reached for comment despite several phone calls to his office and emails.
The issue isn’t just about cost overruns at one institute; it’s about fortifying the foundations of health care, say experts. “There is no central lab in the country that can detect aberrations in biologicals. Nor is there any facility with the drug controller general of India (DCGI, India’s drug regulator) for this purpose,” said Shrikumar Suryanarayan, director general of the Association of Biotech Led Enterprises (ABLE), an industry body based in Bangalore. “It’s very important to have this kind of an institute,” added Suryanarayan, a veteran biotechnologist, who led Biocon Ltd’s research and development for 23 years, quitting it in 2007.
Biologicals are very different from, and more complex than, small (synthetic) molecules that form the basis of traditional allopathic medicines. However, a wide range of them are in use today including enzymes, vaccines, hormones, antibodies and blood products. Increasingly, the world is moving towards living system derived medicines such as stem cells, biological implants and gene therapy. But in the absence of competent testing facilities in the country, biotech and pharma companies have to look overseas to source and send their reference samples (also called “sera panels” or “controls”).
“We are talking of innovation in this country. But the very moment a biotech company has to procure or send biologicals overseas, costs shoot up five times; innovation gets nipped right at the start,” Suryanarayan said.
‘Some issues’
Empty spaces: Another unoccupied animal cage. (Photo: Ramesh Pathania/Mint)
NIB’s cause hasn’t been helped by the drug regulator’s stand. A circular dated 18 July 2007 sent by the office of the DCGI to all port officers of the Central Drugs Standard Control Organization (CDSCO), without marking a copy to NIB, said: “…sending of samples of diagnostic kits (critical/non-critical) and blood products to NIB, Noida, UP, should be stopped with immediate effect till further order… The diagnostic kits/blood product which are required to be evaluated for infectious marker should be sent directly to NICD (National Institute of Communicable Diseases), Delhi; NARI (National AIDS Research Institute), Pune and CMC (Christian Medical College), Vellore for evaluation purposes, etc.”
When asked about this, M. Venkateswarlu, DCGI, said his office had inspected NIB and “found some issues”. People familiar with the matter who did not wish to be identified said two inspections were done, one before issuing the circular, and one in December 2007 to notify NIB for the testing of additional products.
They claim that the results were deliberately “mixed up.” “If NIB labs were not up to the mark, why didn’t DCGI issue an adverse report before stopping the samples in July?” said one of the longest serving staff members of NIB who did not wish to be identified. “DCGI should have legally de-notified NIB before taking any such step,” this person added.
Safety regulations
However, there’s another part to the DCGI circular which brings the larger question to debate. The July 18 circular also says: “In case of the imported consignment of the subject products…post officers of CDSCO are advised to examine the…manufacturing/test or Batch Release Certificate issued from National Regulatory Authority of origin before it is marketed in the country”.
That means these drugs will enter the country based on certificates issued by the regulatory authorities of the country of import without undergoing any testing here.
India imports biologicals-based products from several countries which differ in their regulatory mechanism. For instance, blood grouping reagents are imported from six countries; enzymes of microbial origin are imported from 21 countries; and vaccines (for humans) are imported from 24 named countries as well as some “unspecified” countries, according to the Union commerce ministry’s export import data bank.
In effect, biological drugs from all these countries have been entering India for the past six months at least without undergoing any testing, even as a facility that can test them remains unused.
Now that the country is entering the era of biosimilars (generics of biotech drugs), where there is no original data from the innovator companies for DCGI to compare with, it is even more important that it does more and efficient policing, said Suryanarayan.
A senior executive at a biotech firm said that in the absence of any back-up institution such as NIB, DCGI has to rely on company data for giving approvals. “Other regulatory agencies have their own back-up laboratories,” added this executive who did not wish to be identified.
‘I think the two ministries— health, and science and technology—should take a fresh look at NIB,” said Hota, adding that the government should either privatize it or make it a public-private institute.
The industry seems to find the idea amenable. Executives say since it is expensive to get good people in this field and government institutions cannot pay Rs50-60 lakh as salaries (the kind of annual emoluments that are the norm today), partnering with the industry can rejuvenate the institute. In fact, ABLE thinks it could “work as a first public-private model (in this space)” for the country.
Ambitiously started under a tripartite agreement with a grant-in-aid from the United States Agency for International Development and a soft loan from Japan’s Overseas Economic Cooperation Fund (amounts which the Indian government has since paid up), NIB has been reduced to a white elephant which, people claim, is burning up at least Rs10 crore in annual maintenance.
Udit Misra contributed to this story.
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First Published: Sat, Feb 02 2008. 12 38 AM IST