Wisdom has dawned at long last on the public health establishment of the country. Twenty-five months after stopping production on the orders of the Union Ministry of Health and Family Welfare, three prestigious vaccine manufacturing public sector undertakings (PSUs), the Central Research Institute (CRI) at Kasauli in Himachal Pradesh, the Pasteur Institute of India (PII) at Coonoor, and the BCG Vaccine Laboratory in Chennai are readying to resume vaccine production. Significantly, these three account for a very substantial share of vaccine supplies needed to implement the Universal Immunisation Programme (UIP), one of the most successful government-run public health programmes in the country. CRI and PII are over 100 years old.
The resumption was made possible by the Ministry's revocation of its January 2008 orders “suspending” the manufacturing licenses of these units “till such time all the deficiencies are rectified.” The drastic step was taken on the ground that the plants had violated some licensing conditions, which related to staff strength, size of premises, and quality control as specified under the World Health Organisation's good manufacturing practices (GMP). The suspension was ordered under Rule 85 (1) of the Drugs and Cosmetics Rule, 1945, after the undertakings were found to be not GMP-compliant.
The order revoking suspension, which was issued on February 12, declared that it took immediate effect. While considering the need to revoke the suspension, it said, the Ministry took into account the impact of the production stoppage on the UIP. This was in terms of the availability and the prices of these vaccines after the stoppage of production and also the public interest in maintaining the captive production capacity of these units. (Ever since the immunisation programme was launched decades ago, the share of the three PSUs in the supply of vaccines has been more than 70 per cent; private domestic manufacturers and foreign suppliers account for the rest.)
The revocation order itself is testimony to the government's failure to keep the immunisation programme going. The adverse consequences should have been anticipated: a sharp fall in the supply of vaccines and an abnormal rise in the prices paid to private domestic and foreign manufacturers. For instance, the government, which used to pay PSU Rs. 12 for one vial of 10 doses of vaccine, has now to pay a private manufacturer between Rs. 50 and Rs. 60 for the same quantity of vaccine.
When the three PSUs manufacturing vaccine units were ordered to stop productions, scientists, public health activists, and leaders of the Left parties warned that this reckless action would cause an acute shortage of vital vaccines and throw the immunisation programme out of gear. The Parliamentary Standing Committee on Health and Family Welfare, headed by Amar Singh, was critical of the Ministry for its move to suspend manufacturing in the three PSUs. The Committee in its 38th report highlighted the shocking fact that within two years of stoppage of production in these units, vaccine prices had more than doubled, having major implications for the government's expenditure on the immunisation programmes.
The critics cautioned the government against depending solely on the private sector for sustaining a programme, which is a continuous process requiring non-stop supply of vaccines. In less than five months, their fears came true. According to newspaper reports, at least 15 States and most Union Territories started complaining of shortage of stocks and sent an SOS for further supplies. The government could do nothing but look towards the private manufacturers, who were in no position to deliver. Several States and Union Territories, including Delhi, were agitated over the shortage of vaccines such as tetanus toxoid (TT) vaccines, which are generally administered to pregnant women. Other vaccines in short supply were the diphtheria-pertussis-tetanus (DPT) vaccine and Bacillus Calmette-Gherin (BCG), used in tuberculosis treatment.
There is another shocking feature of the mess. The three vaccine institutes had stocks of vaccines but their hands were tied. They were asked not only to stop production but also to stop despatch of supplies from the stocks they held.
The order suspending production activity in the three units made it clear that it would be in force “till such time as all the deficiencies are rectified.” The government, which runs these units, failed to take any major step to make them GMP-compliant in the two years after production was suspended. It is truly shocking that scientists and technicians involved in a vital field were kept idle for two full years.
All that happened was that three committees visited the units to study the situation. The first was the “Experts Committee” headed by Drug Controller General of India. It studied how best the units could be developed into testing centres. The “Oversight Committee” that followed dealt with issues relating to infrastructure development. Fortunately, a former Union Health Secretary, Javid Chowdhury, who has had long experience in the field of public health, headed the third committee. Applying eminent common sense, it clinched the issue by recommending the revocation of the suspension orders served on the three PSUs in the public interest and on the strength of the compliance status furnished by the institutes. That the three PSUs with commendable records have been put back on their feet is a matter for celebration.
It is, however, unfortunate that media coverage of the goings-on in a crucial sector of public health, which concerns millions of ordinary Indian citizens, has been sporadic, mostly superficial, and on the whole poor. Barring a few English dailies and magazines, the news media failed to cover the government's vaccine fiasco, and the issues at stake, seriously. On this issue, The Pioneer and The Times of India among English dailies and Frontline and Down to Earth among English magazines stood out through their sensitive coverage. Frontline had an authoritative and educative cover story on the vaccine worries.
Readers' Editor clarifies:
“Public health issues: need for more media concern” gave the expansion of BCG as Bacillus Calmette-Ghérin. It is Bacillus Calmette-Guérin (or Bacille Calmette-Guérin).