New data protection norm may hit Indian drug cos

Pharma companies may suffer under revised definition of new chemical entities.

In what could be a major blow to Indian pharmaceutical companies, the government may choose to define new chemical entities (NCE) in a way that would include all derivatives of a molecule.

Thus, data protection would bring into its fold derivatives like salts, esters, polymorphs, combinations or novel drug delivery systems (NDDS).

The matter is under consideration of the committee on data protection appointed by the ministry of chemicals and fertilisers. Headed by the secretary, ministry of chemicals and petrochemicals, the committee is expected to come out with its report in a month's time.

Local pharmaceutical companies have argued for long that the Big Pharma has used this ploy for "evergreening" their patents.

"This is a violation of the definition of patentability. This will undo the specifications in para 3 (d) of the revised Patent Act. Why should one grant data protection to something that cannot be patented?" said a top functionary of an association representing Indian companies.

Para 3 (d) defines whatever cannot be patented in India and includes all forms of incremental innovation which can be collectively called "derivatives" of a drug. Even though Indian drug makers have traditionally specialised in developing derivatives and NDDS, they may not be able to leverage this advantage as the innovators, with their research work ready, are best suited to file for derivatives of the original product, explained an industry analyst.

Sources said data protection could be extended to both patented and non-patented drugs. Patented drugs are also proposed to get data protection cover for six years, running concurrently with its 20-year patent life, while it would be three years for non-patented ones.

"We are considering whether it would be for both patented and non-patented drugs or only the former. Whether we should stick to the definition of patentability as per the patent law or go beyond and look at all drugs that are 'new'... We are in the final stages of these deliberations," said a chemical and petro-chemical ministry official.

The executive authority for drugs would be the drug controller general of India (DCGI) and that for agrochemicals would be the agriculture department, said the ministry official.

An industry analyst said, "This patented and non-patented drugs distinction is very ambiguous as the DCGI doesn't have the databases to check the patent status of everything that's submitted to him." The ministry official conceded that this might throw up a lot of disputes and hence the matter was under the scrutiny of the committee.

At the time of drug approval, the DCGI, under Schedule Y of Drugs and Cosmetics Act, demands exhaustive data from the first applicant of an NCE, ranging from animal pharmacology & toxicity data, pharmacokinetic data and pharmacological actions to reports on various stages of clinical trials.

It is protection of this data that has been a long-standing demand of multinational pharma companies which claim that developing an NCE takes anything from $ 800 million to $1 billion.