Employees of the 100-year-old Pasteur Institute of India are upset over the suspension of licence to produce vaccines.in Coonoor
SCIENTISTS, medical personnel, researchers, technicians and other employees of the Pasteur Institute of India (PII) in Coonoor in the Nilgiri district of Tamil Nadu are deeply agitated over the suspension of the manufacturing licence to the 100-year-old institutes vaccine manufacturing plant. The action came after three rounds of inspection of the institutes premises for the assessment (pre-qualification) of the vaccine production unit in accordance with the procedure established by the World Health Organisation (WHO).
Acting on the findings of the inspection teams, the Central Licensing Approving Authority (CLAA) suspended the licence for production till such time all the deficiencies are rectified, on the grounds that the plant had violated some licensing conditions. The conditions related to staff strength, size of the premises and quality control as specified under the WHOs good manufacturing practices (GMP). The Union Ministry of Health and Family Welfare has said in its office memorandum to the institute that the action followed two rounds of inspection of the production premises, the first one in August 2007 and the second in January 2008. Although only these two inspections find mention, there was one held in November 2007 too. A WHO representative was part of the August 2007 inspection team.
The people of Coonoor do not hide their displeasure over what they call the raw deal to the PII. It is the only Central public sector undertaking operating in the district after the Hindustan Photo Film factory was wound up in 2003. The PII has become part of the peoples consciousness, particularly because it is engaged in a vital service in the public health sphere. Not surprisingly, the Save Pasteur Institute Association comprising peoples representatives has joined hands with the staff of the institute in their protest.
Originally named the Pasteur Institute of Southern India, the PII was started on April 6, 1907, as a hospital exclusively for dog-bite victims, five years after a British woman, Lily Pakenham Walsh, died in India for want of timely treatment for hydrophobia. The institute was developed with Rs.1 lakh, which was part of Rs.50 lakh donated by an American philanthropist, Henry Phipps, for developing medical institutions in India. It was registered as a society under the Societies Act, 1860, and it started functioning as a charitable organisation.
In 1977, the institute was converted into an autonomous body under the Union Health Ministry. It is managed by a governing body headed by the Union Health Secretary ex-officio.
The institute expanded its activities from running a hospital to carrying out research work in preventive medicine and manufacturing vaccines. Its products include DTP vaccines (DPT, or diphtheria-pertussis-tetanus; DT, or diphtheria-tetanus toxoid; and TT, or tetanus toxoid), vero-cell-derived rabies vaccine for human use, and tissue culture anti-rabies vaccine for animals.
The institute is involved in R&D activities such as developing cost-effective tissue culture rabies vaccine and tissue culture-based, cost-effective JE (Japanese encephalitis) vaccine, conducting training programmes, providing consultancy services to scientists within the country and abroad and offering training in vaccine manufacture/biotechnology. Among the facilities in the institute are the Rabies Diagnostic Laboratory, the Dog/Animal Bite Treatment Centre (24-hour service for emergency cases) and the National Polio Laboratory.
The institute has several achievements to its credit. These include the introduction of BPL (beta-propio-lactone) inactivated brain tissue rabies vaccine for the first time in the country in 1970 and the production and release of over one million doses of totally indigenous oral polio vaccine. The institute made substantial contribution to the governments Universal Immunisation Programme (UIP) by supplying cost-effective vaccines. Its vaccines covered the entire needs of Tamil Nadu and Kerala. In respect of DPT, the institute covered up to 60 per cent of the needs of the entire country.
Public health activists in Tamil Nadu question the wisdom of the Union government in contemplating the import of vaccines and the purchase from private manufacturers. They say that there is already a vaccine shortage and express the fear that the cost of vaccines supplied by private manufacturers will be prohibitive.
Imported vaccines will be even more expensive. In Tamil Nadu alone 44 lakh children are expected to go without immunisation in the next two years owing to a shortage of vaccines until the proposed vaccine park comes up in Chengalpattu.
Under the immunisation programme, every year every schoolchild who crosses age 10 and age 16 is administered TT. This covers a total of 22 lakh students a year. Since pregnant women get priority in immunisation, the 10-year-olds and 16-year-olds, numbering 44 lakh, may be denied immunisation in the next two years. Every one-year delay in the manufacture of vaccines will add lakhs of students to the list of losers.
Listing out the achievements of the institute, its Director, N. Elangeswaran, said that in just two years, between 2005 and 2007, the institute doubled its production and earned an impressive revenue of nearly Rs.30 crore.
It is an irony that the PII had to suffer the ignominy of suspending production in its centenary year. On June 19, 2007, Union Health Minister Anbumani Ramadoss launched a new product manufactured by the Institute, a combination of DPT and hepatitis B vaccine, in commemoration of its centenary. He handed over to the institute a modern quality control machine worth Rs.60 lakh with separate divisions for biotechnology, microbiology, and so on. Acknowledging the PIIs crucial role in saving crores of lives, he invited the scientists to prepare a road map for the development of the institute in the next 50 years. Seven months later, the same Minister was to state that the consensus in the Ministry was that the entire vaccine production in the country must be centralised at one new unit.
Significantly, in the intervening period, between the Ministers appreciation of the Institutes contribution and the consensus in the Ministry against the PIIs fitness for centralised production, the joint inspection was conducted by the Drug Inspectors of the Drugs Control Department, Tamil Nadu, and CDSCO [Central Drugs Standard Control Organisation] along with the expert as per the provision of the Rule 78 (d) of D & C Rules, 1945, according to the Office Memorandum.
The memorandum said: It has been reported that facilities, practices and protocols are not in compliance with the provisions of Schedule M of Drugs and Cosmetics Rules. It also said that the non-compliance had been communicated to the PII and the institute directed to show cause as to why the licence granted to the plant should not be suspended or cancelled.
The institute, the memorandum said, stated in its reply dated January 4, that it will not be possible to completely rectify all the deficiencies especially those relating to structure and manpower and would try their level best to rectify the deficiencies within their limits. There is no mention in the memorandum as to who replied for the institute.
The inspecting officers revisited the Coonoor premises on January 9 and 10 and submitted a fresh report. It was on the basis of this report that the CLAA concluded that the institute had failed to comply with conditions of licence in respect of (A) Condition (a) (f) of Rule 78 in not maintaining adequate staff and adequate premises and plant as provided in Drugs and Cosmetics Rules, and (B) Condition (p) is not complied as the good manufacturing practices as laid down in part 1 and part 1-A of Schedule M of Drugs and Cosmetics Rules are not followed/adopted in the manufacture and quality control of the drugs manufactured under licence number 12 in form 28D.
It was on this basis that the Drugs Controller General of India suspended the institutes licence.
A member of the Save PII Association said that the quality of the vaccines supplied by the institute had never been under dispute all these years. Nor were there any complaints worth mentioning.
He said that if the ministry wanted the institute to conform to certain standards with exports in mind, it should have provided the necessary funds to improve the infrastructure and introduce more advanced machines.
The fact that the time between the first enquiry and the issue of suspension order was hardly six months, it is clear that the motive is different, he reasoned. Cant they have a new plant exclusively for export? Why should they kill one developed unit to build a new one? asked one PII employee.
The scientists of the institute are unhappy that they have not been given a fair chance to improve the performance of the production unit in conformity with WHO requirements. Our progress has been steady all along. We have succeeded in experimenting innovative projects. We could see some setback and it was only recently. We had to face numerous hurdles owing to financial constraints and for administrative reasons, said one of the medical personnel.
Problems relating to infrastructure cannot be solved overnight, another employee reasoned. Frequent administrative pinpricks, transfers and victimisation hampered our work, lamented another.
A senior scientist observed, Our institution has a separate identity and is steeped in tradition and as such it should have been given the respect it deserves. The threat of closure held out by a section of the administration for quite some time has united all the 500-odd employees. Almost all parties are with us, all the unions are with us, a Class IV employee said.
A senior officer said, Our performance statement for the past six years shows a steady increase in production in terms of value from Rs.5.59 crore in 2002-03 to Rs.10.47 crore in 2007-08. In fact in 2006-07 it touched Rs.15.43 crore against the previous years Rs.12.64 crore.
The officer continued, We are not against the vaccine park. Nor are we against upgrading or WHO norms, or GMP. In fact, the institute initiated steps in the direction of upgrading even in 2001-02 through quality improvement, but it could not be continued owing to internal problems. The accent was on increasing production, even doubling it.
Exuding confidence, another officer said: Give us Rs.15 crore to Rs.20 crore and six months to one year, we can show that WHO and GMP norms can certainly be achieved. We have enough experience and expertise, adequate infrastructure and staff strength, and the spirit to achieve. We cant bear to see the institution meant for the poor wither away.