Panacea may have secured WHO nod for vaccine

Would enable company to resume supplies of Easyfive pentavalent vaccine for world immunization programmes

At a time domestic drug makers are facing tough regulatory enforcements worldwide, Delhi-based biotechnology firm Panacea Biotec is learnt to have secured an approval from the World Health Organization (WHO) for two of its key Indian units — one each in Lalru (Haryana) and Baddi (Himachal Pradesh).

The move is significant as this would enable the company to resume supplies of its Easyfive pentavalent vaccine for world immunisation programmes.

According to a source, Panacea received pre-qualification for its pentavalent vaccine after WHO authorities inspected both of its facilities earlier this year. The five-in-one vaccine is used for treatment of diphtheria, pertussis, tetanus, haemophilus influenza B and hepatitis B in children.

Prequalification is a process through which pharmaceutical and biotechnology companies have to meet certain WHO-stipulated conditions and standards to become eligible to supply vaccines to the United Nations’ procurement agencies globally. Companies are able to bid for WHO tenders to supply medicines for worldwide health programmes only if their products are prequalified and listed with the agency.

A TROUBLED PAST

• Panacea’s Lalru unit was delisted by WHO in mid-2011, citing irregularities and deficiencies in its quality management system
• Three key vaccines — Easyfive, Ecovac4 and EnivacHB — were also delisted following enforcements at Lalru and Delhi facilities
• In March 2012, Panacea voluntarily withdrew oral polio vaccine from WHO’s list of pre-qualified vaccines, saying the manufacturing unit needed corrective action
• Panacea also lost a chunk of the $222-million three-year WHO contract to supply the Easyfive vaccine to Unicef till 2012

Panacea’s Baddi factory is a newly-built facility and is expected to act as a backbone for the company’s future supplies to global markets, including the US, while the Lalru unit, which primarily manufactures raw material for medicines and vaccines, had been delisted by WHO in 2011 after irregularities and deficiencies were found in quality management system. The move resulted in a major setback for Panacea, which was then manufacturing its key vaccines at its Delhi unit and the raw material at the Lalru one.

Three of the company’s diptheria-pertussis-tetanus-based combination vaccines — Easyfive, Ecovac4 and EnivacHB — were also delisted from WHO’s list of pre-qualified vaccines following enforcement at its Lalru and Delhi facilities.

In March 2012, Panacea had voluntarily withdrawn its oral polio vaccine, or OPV, (also produced at the company’s Delhi facility) from WHO’s list of pre-qualified vaccines, saying the manufacturing unit needed corrective action.

Meanwhile, Panacea also lost a chunk of the $222-million three-year WHO contract to supply the Easyfive vaccine to the United Nations International Children’s Emergency Fund (Unicef) till 2012.

Since then, the company has struggled with its revenues, as it has not been able to participate in most of the global tenders that follow WHO prequalification and are crucial for the company’s business.

In past two weeks, the biotechnology company’s stock has outperformed the broader markets, surging over 60 per cent on BSE, compared with the 4.4 per cent rise in the benchmark Sensex. This was on hopes of a re-listing of pentavalent vaccine in the list of WHO pre-qualified vaccines. The company’s scrip on Wednesday rose 12.46 per cent over its previous close to end the day at Rs 138.05.

According to the source, Panacea recently shifted the Easyfive pentavalent vaccine to its Baddi unit. The expected approval of Panacea’s facilities by WHO and re-listing of the company’s pentavalent vaccine are seen as a major boost for its revenues in the coming quarters, as these might help it grab the next supply deal.

The source said Panacea had undertaken various measures to refurbish the facility and strengthen its quality management system.

Apart from Panacea, Pune-based Serum Institute also manufactures and supplies pentavalent vaccines globally. However, there has been a lot of concern over use of such vaccines in recent times due to reported death of infants in several places where the vaccine was administered. While investigations by governments and WHO revealed there was no causal link between the use of the vaccine and those deaths, the Supreme Court recently directed the government to respond to a public interest suit seeking ban of pentavalent vaccine being pushed as a replacement for the DPT (diphtheria, pertussis, tetanus) vaccine given to infants. The suit alleged the five-in-one vaccine had serious side-effects on children and had resulted in deaths of 21 minors in the country so far. The apex court has also issued a notice to Serum Institute.