3.36% of about 82,600 drugs samples found to be substandard

As many as 2,783 samples or 3.36 per cent of the total 82,599 samples tested by drug controllers of various states and Union Territories in 2017-18 were declared substandard, Parliament was informed Tuesday.

Of the total, 236 samples or 0.28 per cent were declared spurious or adulterated, Minister of State Chemicals and Fertilisers Mansukh L Mandaviya told the Lok Sabha.

In a written reply, Mandaviya said 2,783 samples of drugs were “declared not of standard quality” out of 82,599 samples tested, which is 3.36 per cent of the total.

In 2016-17, the total number of drugs samples tested was 76,721, of which 2,780 were declared not of standard quality, at 3.6 per cent of the total, while 123 samples were found to be adulterated/spurious, the minister added.

Stating that the government has taken various steps to curb the menace of substadard/spurious drugs, he said stringent penalties for manufacturing spurious drugs have been provided under the amended Drugs and Cosmetics Act, 2008.

“Certain offences have also been made cognizable and non-bailable,” Mandaviya, who is also Minister of State for Road Transport and Highways and Shipping, added.

Moreover, the Cabinet Commitee on Economic Affairs (CCEA) has also approved a proposal for strengthening drug regulatory system in India both under the Centre and States at a total expenditure of Rs 1,750 crore.

“Out of this, Rs 850 crore is the central government’s share,” Mandaviya said, adding share of the Centre and states is 60:40 for all states except Jammu and Kashmir, Himachal Pradesh, Uttarakhand, Sikkim and North-Eastern states for which the ratio will be 90:10.

Replying to another query, Mandaviya said fixing of ceiling prices of 856 essential medicines by National Pharmaceutical Pricing Authority (NPPA) has resulted in a saving of Rs 11,462 crore as on November 30, 2018.

He further said the NPPA has been closely watching availability of coronary stents after fixing ceiling prices.

“No shortage has been reported so far in this regard,” the minister said.

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