Drug controllers urged to ensure testing of pharma products before releasing them in market
New Delhi (PTI): The Drugs Controller General of India (DCGI) has urged all drug controllers of the states and Union Territories to ensure testing of raw materials and finished formulations of pharmaceutical products before releasing them in the market in the wake of children's deaths allegedly due to the consumption of contaminated cough syrup in Madhya Pradesh and Rajasthan.
Five children from Madhya Pradesh are in a critical condition, while 20 have died due to kidney infections caused by the consumption of the "contaminated" cough syrup, containing Diethylene Glycol (DEG) and Ethylene Glycol (EG).
Besides, at least three children have allegedly died in Rajasthan after consuming cough syrup in different districts of the state.
In an advisory, the DCGI said that during recent inspections at manufacturing facilities and in the investigations of the drugs declared as 'Not of Standard Quality', it was found that several manufacturers are not testing each batch of excipients and active ingredients for compliance with prescribed standards before use.
The DCGI said that the directorate has, from time to time, emphasised the critical importance of testing of raw materials, including the excipients, before their use in the manufacturing of pharmaceutical formulations.
There have been recent reports of child deaths in Chhindwara, Madhya Pradesh, allegedly linked to contaminated cough syrups and concerns related to the quality of these cough syrups, the advisory said.
"During the inspections carried out at the manufacturing facilities and in the investigations of the drugs declared as Not of Standard Quality, it was observed in the reports that the manufacturers are not carrying out testing of each batch of the excipients/inactive and active pharmaceutical ingredients for verification of compliance with the prescribed standards before using them in the manufacture of formulations and also in the finished products," the advisory dated October 7 said.
The advisory highlighted that according to Drugs Rules, including rule 74 (c) and rule 78 (c) (ii), the licensee shall, either in his own laboratory or in any laboratory approved by the licensing authority, test each batch or lot of the raw material used by him for the manufacture of his product and also each batch of the final product, and shall maintain records or registers showing the particulars in respect of such tests as specified in Schedule U.
"All the State/ UT Drug Controllers are requested to take measures to ensure testing before the manufacture and release of the batch to the market by way of monitoring during inspections, sensitising the manufacturers through circulars, etc.
"Further, it shall also be ensured that the manufacturers have a robust vendor qualification system in place and use raw materials, including excipients, from reliable approved vendors only," the advisory said.
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Ex-PM Devegowda warns opposition of electoral losses if they continue to allege 'vote chori'
New Delhi (PTI): Former Prime Minister H D Devegowda on Monday said the Opposition parties would "suffer" if they continue to raise allegations of "vote chori" and create suspicion in the minds of voters by blaming Prime Minister Narendra Modi-led government.
Participating in a discussion on election reforms in the Rajya Sabha, he criticised the Opposition for making a mockery about the Prime Minister "in the streets and on the public platform".
"This (India) is a very big country. A large country. Congress may be in three states. Remember my friends please, by using the words 'vote chori' you are going to suffer in the coming days. You are not going to win the battle," Devegowda said, referring to the Opposition members.
He asked what the Opposition is going to earn by "blaming Narendra Modi's leadership and creating a suspicion in the mind of the voters" through the claims of "vote chori".
"What has happened to their minds? Let them rectify," Devegowda said.
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The former prime minister said that during his over seven decades of public life, he has never raised such issues of vote theft despite facing defeat in elections.
He also cited a letter written by the then Prime Minister Jawaharlal Nehru regarding inclusion of "18,000 votes" (voters) in Kerala.
"Why I am telling this (because) during the Nehru period also, there were certain lapses in the electoral system," said Devegowda, who was the prime minister between June 1, 1996 and April 21, 1997.
He said that the Congress party faced defeat in the recent Bihar elections despite raising the issues of mistakes in the electoral rolls.
"What happened after that even after so much review (of voters list). Think (for) yourself! You got six MLAs," the senior Janata Dal (Secular) leader said.
Devegowda questioned the Opposition as to why they want to make allegations against the prime minister on the issue of the voters list?
"Election Commission is there. Supreme Court is there. The Election Commission has given direction to all the state units to rectify all these things," he said.
Devegowda said people of the country have full confidence in Narendra Modi's government and it will come back to power after the next Lok Sabha elections as well.
K R Suresh Reddy, Bharat Rashtra Samithi (BRS) party's Rajya Sabha member from Telangana, said that electoral reforms are the backbone for a healthy democracy.
He said a large and diverse nation like Indi needs clean electoral rolls.
Asserting that strict re-verification should not become a mechanism for exclusion, Reddy said no eligible voter should lose their right to vote simply because accessing paperwork is difficult.
He said while the concern definitely is on the voters' exclusion, "we should also be equally concerned about the percentage of voting."
"What is happening in voting today? Once the election ends, the drama begins. The biggest challenge that the Indian democracy has been facing in spite of two major Constitutional amendments has been the anti-defection. Anti-defection is the name of the game today, especially in smaller states, especially where the legislatures are small in number," Reddy said.
The senior BRS leader suggested creation of a parliamentary committee "which would constantly look into the defection" and "ways and means to cutting that".
AIADMK's M Thambidurai raised the issues related to election campaigning.
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"Election campaigns are one of the important election processes. In that, political parties must be given the proper chance to campaign," he said and cited problems faced by his party in Tamil Nadu in this regard.
Thambidurai said political parties were facing hardships in Tamil Nadu to conduct public meetings and to express their views to the public.
YSRCP's Yerram Venkata Subba Reddy stressed on bringing electoral reforms at both the state and national levels.
He also suggested replacing Electronic Voting Machines with paper ballots in all future elections.
"EVM may be efficient but can't be trusted. Paper ballot may not be efficient but can be trusted. You need trust in democracy," Reddy added.
