The 60 year old BCG Lab in Chennai, the 103 year old Central Research
Institute (CRI) in Kasauli, and the 101 year old Pasteur Institute of
India (PII) in Coonoor were closed down by the Government in January 2008
for failing to comply with good manufacturing practices (GMP) laid down by
the WHO. The government planned to convert them into testing facilities;
with vaccines to be produced in a proposed unit at Chennai, expected to be
functional by 2012. This has resulted in a short supply of vaccines as the
entire BCG for the country was being produced in the BCG lab and CRI was
the only production center for the yellow fever vaccine in South East
Asia. Other vaccines including DPT, anti rabies vaccine, typhoid vaccine
are also hit. In view of the crisis, an expert committee headed by the
Drug Controller General of India has submitted its recommendations for the
revival of the 3 companies.
The current Indian market for vaccines is around Rs
1000 crore with a projected growth rate of 25%. But the space is dominated
by vaccine majors like Glaxo SmithKline Beecham, Merck, Aventis Pasteur,
Chiron and Hoescht. What went wrong with indigenous vaccine manufactures
in India? The story is interesting. To protect their soldiers in India,
the Britishers had established the above mentioned institutions in the
early 1900’s for development and manufacture of vaccines. In fact, David
Semple first developed the anti rabies vaccine in CRI Kasauli. Post
Independence, we lost the early advantage; research and development was
neglected, and vibrant institutions became mere production units.
PII which had initially started producing OPV from seed
virus procured from Sabin, abruptly stopped production. Today we import
bulk OPV which is being bottled entirely by the private sector. In 1987,
the Department of Biotechnology (DBT) established a modern vaccine
production unit, Bharat Biologicals and Immunologicals Corporation Ltd.
(BIBCOL) in Bulandshahar in Uttar Pradesh, a polio endemic area, to meet
the WHO’s good manufacturing practices (GMP) norms. It began by packaging
bulk obtained from Moscow and intended to produce indigenously within five
years from the seed that was to be transferred from Russia. Until 2000,
BIBCOL produced OPV and even supplied 70 million doses to UNICEF; it even
made profits. But it was discontinued abruptly because the Moscow bulk was
not WHO-pre-qualified and, as WHO regulations were now strictly enforced
by importers, the product was rejected by international agencies. It was
again revived and now the irony is that although BIBCOL is in the OPV
business, it is merely repackaging bulk from the same source as the
private players.
In 1989, the DBT established another state-of-the-art
unit called Indian Vaccine Corporation Ltd. (IVCOL) in Gurgaon for the
purpose of producing vero-cell-based IPV and measles vaccines using
technology to be transferred by the French public sector unit, Institut
Merieux, under the Indo-French Agreement. But, in spite of paying part of
the fees for technology transfer, the project fell through because, in the
meanwhile, the French government sold the company to a Canadian firm.
A 2005 paper in the journal PLoS Medicine states: "The
inability of the Indian public sector to recover from its mounting
failures to achieve self-sufficiency and self-reliance in primary vaccines
is also related to liberalization and globalization of the Indian economy.
It is no longer fashionable to produce vaccines in the public sector in
India, let alone try and revive failing public sector units, even if
essential vaccines are not available in the private sector".
The challenge remains — to transform tired government institutions into
successful and internationally competitive units. (The Economic Times 7
January 2009, The Times of India 18 Dec 2008, Frontline April 11, 2008).