Govt lacks personnel, equipment to test one in every two of all biotech products on sales, even as market is growing at 21% yearly.
More than half the biotechnology products in the market — diagnostic devices, blood reagents and even some new drugs and vaccines – have marketing approval in the country without any quality ascertaining certificates from government laboratories.
Although the companies that market such products take regulatory approval from the office of the Drugs Controller General of India (DCGI), by producing quality test results from other countries, the risk of some of these products turning out to be not-of-standard remains high, experts warn.
| A GROWING MARKET Leading biotech products and domestic producers | |
| Product | Companies |
| Insulin | Wockhardt, Biocon, Shreya Life Sciences |
| Erythropoietin | Emcure, Ranbaxy, Intas |
| Hepatits B Vaccine | Shantha, Panacea,Bharat Biotech |
| G-CSF | Dr Reddys, Intas |
| Streptokinase | Bharat, Cadila |
| Interferon alpha 2b | Shantha |
| Rituximab | Dr Reddy’s Laboratories |
| This list is only indicative and does not suggest the regulatory test-based approval status of these products | |
“We approve the products on the basis of quality certificates given by regulators in developed countries. But that does not mean we should not have testing facilities here. There is a requirement. Our capabilities should be augmented in the public interest,” a senior DCGI official said. DCGI does not maintain a separate list of biotech products specifying details of quality testing or certificates.
In fact, in a statement to the Lok Sabha last month, health minister Ghulam Nabi Azad had stated that manpower and capacity building issues were not confined to biotech products. According to the minister, some of the drug testing laboratories of state/Union territory governments were also not functioning properly. “For example, in the states of Jharkhand and Chhattisgarh, the drug testing laboratories are not functional because of manpower shortage. The state governments are responsible for their functioning,” the minister had noted.
He had also said there were no reports of deaths on account of administration of untested drugs, “as it is mandatory for the manufacturers to test each batch before release for sale”.
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On the ground
According to health ministry officials, the rejections that happen in products that undergo quality tests in the two statutory labs – the Central Drug Laboratory (CDL), Kasauli, and National Institute of Biologicals (NIB), Noida — and the increasing volume of biological product imports also point to the need for wider regulatory tests.
CDL has a mandate to test every batch of vaccines for quality assessment before regulatory approval. It is handling all conventional vaccines, but has not upgraded itself to test dozens of combination and new generation vaccines. A vaccine for Japanese Encephalitis, a perilous affliction for thousands each year, is one such example, where CDL has not developed test capability.
“The Kasauli facility should be upgraded urgently. They need equipment, funds and people to carry out all tests. It’s not only that the lab is not equipped to test all vaccines; it cannot even handle the ones for which it is well equipped in a time-bound manner,” said Varaprasad Reddy, founder of the Hyderabad-based Shantha Biotechnics.
“We have faced this problem more than anyone else because we introduced the first indigenous recombinant DNA technology-based product in this country. It took seven years (1990-1997) for us to get the authorities to finalise a testing protocol for this product,” Reddy added.
Shantha is today a subsidiary of European drug multinational Sanofi Aventis and Reddy continues to hold minority shares in the company.
The status of NIB is worse. It is the only government institution empowered to certify the quality of all biological products, except vaccines, but has the capability to test just 69 of the 215 biological products approved in the country. Globally, there are 323 categories of biological products being marketed.
The urgency
Key biologicals for which NIB is yet to develop testing facilities include enzymes and hormones such as the recombinant streptokinase injection, heparin sodium injection, progesterone injection and human growth hormones.
The need to ramp up the country’s test capability is also crucial due to the fast growth of the Indian biotech market. The Association of Biotech Led Enterprises puts the current size of the domestic biotechnology market at Rs 20,000 crore, with a 21.5 per cent annual growth. At the current rate of growth, it is estimated to touch Rs 50,000 crore by 2015.
In 2010-11, the NIB, with a capability to test just 11 types of blood reagent samples, had rejected five per cent of all test samples. However, it is yet to acquire the capability to check the quality of another 16 types of such reagents that are used for diagnosis of human blood groups before any transfusion, posing a risk to critical care patients.
Similarly, while NIB conducts tests on six blood products like human albumin (used in major surgeries, critical heart treatments, etc), it does not have the expertise to test at least 21 other products in the same category.
In the case of diagnostic kits in the market (to identify cases such as HIV, HBV, HCV, syphilis, etc), the NIB can test 20 types of products but leaves out at least 18. The kits for diagnosis of Hepatitis A, measles, pregnancy, malaria, dengue, cancer markers, cardiac markers and thyroid markers are all among those marketed without regulatory testing in the country.
In February, a team of Indian drug regulatory officials are scheduled to visit China to inspect the quality standards of imported HIV kits that were manufactured in some units in the Zhejiang and Fujian provinces of that country. The basis of this inspection was the negative results thrown out by NIB tests a year earlier.