Drug regulator initiates probe
After WHO links children deaths in Gambia to cough syrup made in India
New Delhi (PTI): A probe has been initiated by India's drug regulator after the WHO issued an alert saying cough syrups manufactured by an Indian firm could potentially be linked to the death of children in The Gambia, official sources said.
The World Health Organisation (WHO) on Wednesday warned that four "contaminated" and "substandard" cough syrups allegedly produced by Maiden Pharmaceuticals Limited based in Haryana's Sonepat could be the reason for the deaths in the West African nation.
The sources said the exact "one-to-one causal relation of death" has neither been provided by the United Nations Health Agency nor the details of labels and products been shared by it with the Central Drugs Standard Control Organisation (CDSCO), enabling it to confirm the identity or source of the manufacturing of the products.
"Based on available information, the CDSCO has already taken up an urgent investigation into the matter with regulatory authorities in Haryana.
"While all required steps will be taken, as a robust regulatory authority, the WHO has been requested to share with CDSCO at the earliest the report on the establishment of a causal relation to the deaths with the medical products in question, photographs of labels/products etc," the sources said.
According to the sources, the WHO had on September 29 informed the Drugs Controller General of India that it was providing technical assistance and advice to The Gambia.
It had highlighted that a significant contributing factor to the deaths was suspected to be the use of medicines which may have been contaminated with Diethylene Glycol/Ethylene Glycol, and said its presence had been confirmed in some of the samples it tested.
The CDSCO said it responded to the WHO within an hour-and-a-half after receiving intimation, by taking up the matter with the state regulatory authority.
A detailed investigation was launched to ascertain the facts and details into the matter in collaboration with Haryana State Drugs Controller, the source explained.
From the preliminary inquiry, it has been made out that Maiden Pharmaceutical Limited is the manufacturer licensed by the state drug controller for the products under reference, and holds manufacturing permission for these products.
"The company has manufactured and exported these products only to The Gambia so far," the source said.
It is a practice that the importing country tests the products for quality before sanctioning their usage there.
As per the tentative results received by WHO out of the 23 samples tested, four samples have been found to contain Diethylene Glycol/ Ethylene Glycol as indicated.
It has also been informed by WHO that the certificate of analysis will be made available to it in near future and WHO will share it with India.
"At the same time, the exact one-to-one causal relation of death has not yet been provided by WHO, nor have the details of labels/ products been shared by WHO with CDSCO enabling it to confirm the identity/ source of the manufacturing of the products," the official source stated.
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TVK falls short within touching distance; what next to ensure majority
Chennai (PIT): With TVK falling 10 short of a majority, its leader Vijay has the option of forming a minority government in Tamil Nadu without any outside support, analysts said on Tuesday.
Senior political analyst Sumanth Raman told PTI that the TVK is likely to opt to be a minority government with outside support.
"Since it is the single largest party, TVK has the option to go for that. I don't think he (Vijay) will opt for official support from other political party's MLAs", he said.
"If he opts for minority government, the only thing is that, Vijay will have to prove the support once again after six months".
Raman also pointed out that in 2006 when DMK won only 92 seats, the then party president, the late M Karunanidhi formed a minority government with outside support.
In a completely unexpected turn of events in the Tamil Nadu Assembly elections, the TVK has emerged victorious, putting an end to the almost six decade-long dominance of the two major Dravidian parties--DMK and AIADMK.
By clinching victory in its debut electoral contest, the party has elevated its status to that of a recognised political entity. However, the Vijay-led TVK did not secure a mandate large enough to form a government with an absolute majority on its own, requiring another 10 to cross the finish line. Experts have varied opinions.
Specifically, to attain a simple majority, a political party must win at least 118 out of the total 234 constituencies. The TVK, however, secured victory in 108 constituencies. Given that the TVK fell short of the majority mark, what might unfold next?
TVK leader Vijay has won in both constituencies he contested--Perambur in Chennai and Tiruchirappalli East. As per the election commission rule, he will have to resign from one of these seats. TVK sources said that the leader is likely to surrender the Tiruchirappalli assembly seat.
If Vijay does so, the party's total tally of seats will decrease by one. Then it will be 107. Adding to the number games, TVK appointed Speaker of the Assembly will be ineligible to cast a vote during a confidence motion and the party's effective voting strength will be reduced by yet another seat, which comes to 106.
Accordingly, the TVK requires the support of an additional 12 members to demonstrate its majority. As of now, within the DMK alliance, the Congress party has secured five seats, the two Communist parties have won two seats each (totaling four), while the DMDK has secured one seat, the Indian Union Muslim League (IUML) has won two seats and the VCK has secured two seats.
Within the AIADMK alliance, the PMK has grabbed four seats, the BJP has won one seat, and the AMMK has secured one seat. Going by the calculations, if TVK gets the support of other parties within both alliances, it would gain an additional 21 seats.
TVK could potentially secure a total of 129 seats (108 + 21). However, the TVK does not require the support of all those parties, and the backing of just 12 members would suffice.
As Vijay is expected to visit Lok Bhavan on Wednesday (May 6) to meet the governor Rajendra Vishwanath Arlekar to stake claim to form government, the governor is expected to offer the TVK two options.
First, he may summon the TVK chief and instruct him to demonstrate his majority on the floor of the legislative assembly. Alternatively, he might ask Vijay to gather letters of support from "allied" parties and submit them to him.
If the TVK secures support exceeding 118 seats, the governor would invite the party form the government. If TVK fails to garner support from other political parties, it will be denied the opportunity to form the government.
In such a scenario, the governor has the option to invite the DMK, the party holding the second-highest number of seats to form the government.
If DMK too is unable to form a government, the state of Tamil Nadu will come under governor's rule for the subsequent six months. Following this period, fresh legislative Assembly elections will be once again held across all 234 constituencies.
Another political analyst Durai Karuna ruled out that TVK will go for a minority government.
"If he (Vijay) gives an appeal, many political parties including Congress, VCK and left parties will join TVK", he claimed. "In addition, the AIADMK, which has decided to organise MLAs meeting on Wednesday, might also announce that it would support TVK unconditionally".
He said a clear picture on Vijay's decision will emerge in a couple of days.
Tharasu Shyam, political critic, claimed that Congress was "holding talks with Vijay."
"From now on, the DMK must change its approach and this applies equally to the AIADMK," he said in an apparent reference to some reported difference of opinion between allies DMK and Congress over seat-sharing and power-sharing ahead of the April 23 polls.
Incidentally, AICC in-charge for Tamil Nadu, Girish Chodankar, on Tuesday admitted that the Congress party leadership's decision to stick with the DMK alliance went against strong grassroots sentiment favouring the TVK.
"The local leaders, the grassroots level leaders, were suggesting if Rahul Gandhi, who has a large acceptance in Tamil Nadu, joins the campaign with Vijay, it will create a big impact and we can sweep the Tamil Nadu polls, and get somewhere around 180-190 seats," Chodankar told PTI Videos.
