Report on vaccine unit licence suspension slams Ramadoss

The report has been submitted to the Health Ministry and will be tabled in Parliament next month.

According to sources,the report says that despite the critical nature of the issue,handling of it by the ministry and the Drug Controller General of India’s (DCGI) office was “extremely unsystematic”. “From the records one gets an impression that the issue was thrown around from side to side,indicating disinclination on the part of the officials to take a decision,” the report says.

Further slamming the Health Ministry’s role,it adds that after the manufacturing units had replied to the showcause notices,the decision to suspend their licences “was not taken anywhere on the records of the ministry”.

“The file moved from level to level without any final order being issued to the DCGI. The DCGI took the decision to suspend the licences on his own authority.” The 30-page report also questions the “exceptional” attention paid to these units by regulatory authorities,calling it “eye catching”.

Noting that the units were inspected time and again — more than 4,000 inspections were held from 2004-2009 — it says: “While diligence in regulatory duties is something which should be commended,it must not take the shape where it is perceived that these units are particularly targeted.”

The ministry’s decision in 2008 to suspend the licences of the PSUs,on the ground that these were more than 100 years’ old and that it would take years to make them GMP (Good Manufacturing Product) compliant as required by the WHO,had received a lot of criticism. Some MPs had called the move an attempt to sell the land on which these PSUs stood,to dismantle them and to help out private companies.

A committee headed by former health secretary Javid Chowdhury,with Dr V M Katoch,Director General,Indian Council of Medical Research (ICMR) and Dr R N Salhan,ex-additional Director General of Health Services (DGHS) as members,was formed to look into the issue.

Sources say the report submitted by the panel notes that the “suspension of public sector production” left the public health system dependent on private suppliers. “In 2008-09,the prices of vaccines went unexpectedly high,” it adds.

Opposing the closure of the PSUs,it adds: “(By this) the country will be exposing itself to vaccine insecurity for five year. The private sector manufacturers of vaccines are relatively recent and the experience they draw is largely through the technical staff of public units who are either retirees or have been poached from PSUs.”