Two years after he was accused of acting against country’s national interest by producing a report that apparently favoured multinational drug companies — to the detriment of generic manufacturers with India — eminent scientist R A Mashelkar has been redeemed by the government which has now accepted all recommendations contained in that report.
Mashelkar, as head of a Technical Expert Group that had four other members, had been asked by the government in 2005 to examine whether the grant of patents for pharmaceutical substances could be limited only to ‘new chemical entities’ and ‘new medical entities’ involving one or more inventive steps, or they could be granted to ‘incremental innovations’ on existing drugs as well.
The Mashelkar Committee, in its report in February 2007, had concluded that under the TRIPS (Trade Related Intellectual Property Rights) Agreement, to which India is a signatory, ‘incremental innovations’ would have to be granted patents. The committee also found that patents could be obtained on micro-organisms as well, another sensitive issue for Indian pharmaceutical companies.
The report had been severely criticised by many generic drug manufacturers and industry associations but a major controversy began only after it was discovered that one of the paragraphs in that report, backing the findings, was an exact reproduction from a submission made to the committee by a UK-based lawyer, who had represented multinational drug companies in the past, but without any attribution. Mashelkar, who served as the Director General of Council of Scientific and Industrial Research (CSIR) for 11 years, was accused of plagiarism and this charge was used to trash the entire report by many organisations and political parties.
Owning responsibility for the ‘technical’ error, Mashelkar — who has won famous international battles for the country on patents of neem, basmati and turmeric — had resigned from the committee but stood by the findings of his report. His resignation, however, had not been accepted by the government which persuaded him earlier this year to submit a fresh report on the same matter.
The fresh report, submitted in March this year, came to the same conclusion, backed by some additional technical and legal arguments, and has now been accepted by the government.
“TEG (Technical Expert Group) has come to the conclusion that it would not be TRIPS compliant to limit the grant of patent for pharmaceutical substance to a new chemical entity or to a new medical entity involving one or more inventive steps. It would also not be TRIPS compliant to exclude micro-organisms from patenting. This view has been accepted by the government,” said Secretary, Department of Industrial Policy and Promotion, Ministry of Commerce, in a letter signed on August 5.
Mashelkar told The Sunday Express that he was happy that truth had finally prevailed. “I appreciate the fact that the government has reposed faith in me despite attempts to question my integrity by certain groups. As I have said earlier, an inadvertent technical error in the drafting of the report cannot be used to trash the solid scientific and legal arguments on which it is based,” he said.
The fresh report has the signatures of three of the four other members of the committee — Prof Goverdhan Mehta, Prof N R Madhava Menon and Moolchand Sharma. The fourth, Prof Asis Dutta, had ceased to be a member following his resignation after the controversy broke out in 2007.
