J&J’s licence to make baby powder cancelled - “We have not suspended the licence, we have cancelled it"

 

The Maharashtra Food and Drug Administration has cancelled Johnson and Johnson's (J&J) licence for manufacturing cosmetics, following complaints of carcinogenic substances residue in its talcum powder for infants.

The complaint relates to 15 batches of talcum powder, comprising 160,000 containers, manufactured in 2007, by the company at its facility in Mulund, a Mumbai suburb. The J&J baby powder has a three-year shelf-life.

“We have not suspended the licence, we have cancelled it. The company cannot manufacture the Johnson baby powder at this stage,'' confirmed K.B. Shende, Joint Commissioner (Drug), Maharashtra FDA.

Speaking to Business Line, Shende told that “The company has been using ethylene oxide in its skin powder for infants. The sterilisation process using the chemical is completely wrong, for it remains as a residue. With usage, the talcum powder could turn carcinogenic and cause irreparable damage''.

Following complaints, the Maharashtra FDA carried out a series of investigations and laboratory tests on some containers and found “unacceptable levels of ethylene oxide, which is a main trigger for cancer. We found ethylene oxide residue, which was used to bring down the microbial load in the powder”,' said Shende.

A J&J official said the FDA raised concerns about ethylene oxide treatment, which is not part of the manufacturing process as submitted to the FDA. The shelf-life of the concerned batch ended July 2010.

J&J has up to June to plead its case before the State Government. “We have followed the due process of law. The company can now take up the matter with the State Government, if it wants to continue to manufacture the baby powder at its plant,” said Shende.

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Draft bill gives FDA authority over some pharmacies

The Food and Drug Administration would gain greater authority over pharmacies that compound sterile drugs and ship them across state lines under proposed legislation announced on Friday.

The proposal from a bipartisan group of U.S. senators comes in the wake of a meningitis outbreak last fall that killed 53 people and sickened more than 700. The outbreak was linked to a tainted steroid distributed by the New England Compounding Center.

The proposal would draw a distinction between traditional compounding pharmacies, which make drugs based on specific prescriptions for individual patients, and those such as NECC, which make products without prescriptions for physicians to keep for future use.

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Novartis loses 7 years old battle

The apex court on Monday ruled that the compound for which Novartis was seeking a patent "did not satisfy the test of novelty or inventiveness" required by Indian law.

After the landmark ruling, activists say it will protect access to cheap generic versions of drugs in developing nations.
Novartis fought a seven-year legal battle to gain patent protection for an updated version of its blockbuster cancer drug Glivec, arguing that the compound was a significant improvement because it is more easily absorbed by the body.

API Active Pharma Ingredients are the substances which goes inside the body and fights against the diseases. But to make it easily soluble in body there are various formats which is created by the pharma companies and these are typically patented in US EU and Japan, but SC in India said that unless it is advanced than its earlier form and give a substantiate benefit it can not be called as significant improvement and patent can not be done and hence its rejecting Novartis's claim.

This is a landmark ruling which will pave way the path for drug companies in developing economics to produce generic versions of lifesaving drugs and a major jolt to the big MNCs plan to reap benefit from the disease prone big population in these countries..