The pharmaceutical industry has welcomed the Mashelkar Committee report on spurious drugs, which has recommended death penalty for those who cause "grievous body harm or loss of life".
The industry now wants the government to implement the report at the earliest to curb the spurious drug business. The industry has been hit hard by the menace of spurious drugs, which now accounts for a fifth of the Rs 20,000 crore (Rs 200 billion) pharmaceuticals industry.
"The industry is very pleased with the report submitted by R A Mashelkar. However, the next crucial step is the nod of Parliament which the industry is waiting for with bated breath," said Harinder S Sikka, senior president (corporate affairs), Nicholas Piramal.
The report is a positive step in the direction of putting an end to the spurious drug business. Everything that we had asked for is present in the report, said an industry source.
The committee, in its report submitted to Sushma Swaraj on Tueday, asked for the Drug and Cosmetics Act to be suitably amended and recommended death penalty for sale and manufacture of spurious drugs causing grievous hurt or death.
There is also a need to make a distinct provision in the Drug and Cosmetics Act itself declaring all offenses related to spurious drugs as cognisable and non-bailable, the report added.
The report has proposed the setting up of Central Drug Administration, which it believes could be established by elevating the Central Drug Standards Control Organisation.
"A strong well-equipped and professionally managed CDSCO, which could be given the status of Central Drug Administration was the most appropriate solution," the committee said.
The report said the existing infrastructure at the central and states level was not adequate to perform the assigned functions efficiently and speedily. However, creating another authority would not solve the problem, it said adding that it was essential to strengthen the existing organisations.
Noting that most of the cases relating to spurious drugs remained undecided for years, the committee suggested a separate provision for speedy trials of such offenses.
As the onus of monitoring drug manufacturing standards, drawing and testing of samples and taking legal action against infringers rested with state drug regulatory agencies, it was essential that the state governments strengthen and support their drug control organisations, the committee said.
The problems of fake drugs were also owing to inadequate testing facilities, shortage of drug inspectors, non-uniformity of enforcement, lack of specially-trained cadres for specific regulatory areas, non-existence of data bank and non-availability of accurate information, it said.
The committee also recommended a scientifically and statistically valid study to evaluate and quantify the extent of the problem of spurious drugs at various levels in the supply chain at the regional and national levels.
The government should provide the funds for the study, which should take place at the earliest, it added.
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