HLL Biotech launched two vaccines this year and is also working full throttle towards reviving three vaccine-manufacturing PSUs. Does it have the makings of a success story that will put the public sector back into action. By Shalini Gupta
February 2015 saw HLL Biotech, a subsidiary of HLL Lifecare, launch two new vaccines from its stable — Pentahil (Pentavalent vaccine) and Hivac-B (Hepatitis B), signalling the relaunch of the public sector into vaccine industry. According to the company, this has been a significant achievement of the ‘Integrated Vaccines Complex’ project that started in 2012 after the government issued a directive to upgrade three other vaccine-manufacturing PSUs — the Pasteur Institute of India (PII), Coonoor, in Tamil Nadu, BCG Vaccine Laboratory (BCGVL) in Chennai and Central Research Institute (CRI), Kasauli and assigned HLL to the task.
Progress on track
HLL Biotech formally started functioning from TICEL park, Chennai in July and the IVC project began the same year in Chengalpattu with an estimated cost of Rs 594 crores to research, manufacture and supply vaccines to the government’s Universal Immunisation Programme. Talking about the progress made so far, M Ayyappan, Chairman and Managing Director, HLL Lifecare says, “The launch of both these vaccines was initially estimated in 2016, however, we have been able to launch them a year before in 2015 itself due to a loan licensing arrangement with Biological E, Hyderabad. We are in the market now.” He hopes that the project which is halfway through, will be fully completed by September next year after completing the necessary regulatory requirements.
The company is also working towards vaccines for Hib, measles, rabies, JE and BCG. Once the facility is complete it is expected to produce 40 million doses of rabies vaccine, 25 million of JE, 140 million of Hepatitis B and 100 million doses each for the rest. While the technology for rabies has been developed in house, it has partnered with Biological E for Hepatitis B and BCGVL for BCG.
“JE vaccine uses live attenuated vaccine imported from China, but manufacturing it poses a regulatory hurdle since it involves killing of hamsters. Hence, we are looking at killed vaccine, which we have proposed to the government,” pitches in Ayyappan. He is quite confident when he says that the facility will be a WHO approved one to cater to the export market. It will also be producing new vaccines towards the end of this year, apart from the ones it has been given a mandate for. Technical staff for the same has been recruited.
Out of the three institutes, CRI, Kasauli is functional now and has been revived with an investment of Rs 49.83 crores. Mechanical construction of BCGVL will be complete by this month end. However, validation of the facility and training is still left. The facility received GMP certification in December 2012 after NRAI inspection and production was started. Post CGMP certification, it is slated to produce 80 million doses annually. Pasteur Institute’s revival(Rs 144 crores) has been a bit delayed due to several factors, construction work is ongoing and it is expected to be completed by February 2016. Ayyappan notes that the real challenge will be capacity building of existing people to build the cGMP facility.
Reinventing the wheel
Dr Krishna Ella, Chairman and Managing Director, Bharat Biotech and President, Vaccine Manufacturers Association of India, disagrees vehemently with what he terms as a ‘backward approach’ of the government of reviving PSUs. He cites the example of a developed country such as the US and a developing nation (China). In both these countries vaccines were being manufactured by the public sector; by state governments in the US during 1970-80 and 10-12 provinces in China from early 90s to 2000. However, given the technological challenges, governments realised that it was difficult to maintain the facilities since they need to be upgraded. While some companies were acquired, others shut down. Private companies now dominate the industry in these countries.
He reiterates, “US and China have already burnt their fingers with this approach, and we are again going the same path. All three PSUs could have been upgraded with lesser investment earlier since the facilities were already existing. What has been done is only going to open a Pandora’s box.”
It is to be noted that the Government of India is buying Rs 600-crores worth of vaccines annually from the private and public sector for the UIP out of which 75 per cent is currently coming from the private sector. This is just two per cent of the total budget earmarked for the health ministry (Rs 30,000 crores). And when asked about vaccine security, he is quick to add that the government can easily achieve that by signing an agreement with companies and fix a price to ensure that it is affordable to the masses. He also elaborates that vaccine manufacturing is a complex business, since all vaccines are treated as new drugs, requiring rigorous clinical trials as well as upgradation of facilities in every two years. “The price of vaccines supplied by the private sector in India is much cheaper. I think that the vaccines manufactured by the public sector will be priced high,” he quips.
Vaccine rush?
Even as we debate if the public sector introduction of vaccines will be a success, Dr Y Madhavi, Senior Principal Scientist, National Institute of Science, Technology and Development Studies (NISTADS), an institute under the Council of Scientific and Industrial Research (CSIR) offers a perspective. She feels that the Government of India is introducing new vaccines into the Universal Immunisation Programme (UIP) without taking cognisance of epidemiological data, disease burden and the safety and efficacy studies. She cites the example of Hib-containing pentavalent vaccine which is intended to replace two other pre-existing UIP vaccines-DPT (diphtheria, pertussis, tetanus) and Hep B (hepatitis B). “With a low incidence rate of 0.007 per cent, there is no need for the introduction of Hib. Also, several deaths have been reported following vaccination with pentavalent vaccine along with adverse reactions with a PIL that is now in Supreme Court,” she asserts.
She also adds that the rotaviral disease burden in general population is low and most of the data has been extrapolated based on hospital studies which questions the introduction of the rotavirus vaccine as well. As we move from oral polio vaccines to Injectable polio vaccine, she quips that IPV was there even when OPV existed, it only now that we know OPV doesn’t work in certain communities. “I strongly recommend a review of vaccines in the UIP which is based on evidence,” she adds. On affordability of vaccines she is quick to add that price is not everything, instead there needs to be a cost benefit analysis in view of public health while thinking of ways to complement it with preventive medicine.
Meanwhile, as the world celebrates Immunisation week, Ayyappan hopes that the IVC along with the three revived PSUs will work in tandem to gear up India in a position to introduce new generation vaccines in the immunisation programme. Whether or not the public sector can raise its head will be revealed in time, once economies of scale have been achieved, the government though needs to ensure that adequate measures are taken to boost the industry while learning from hindsight as we move into the future.
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