Companies & Sectors
Lupin gets FDA nod for generic Ambien CR extended-release tablets

Lupin’s US unit will soon commence marketing the tablets used for the treatment of insomnia characterized by difficulties with sleep onset or sleep maintenance

Pharmaceutical company Lupin Ltd (Lupin), said it received a final approval for its Zolpidem Tartrate extended - release tablets USP 6.25mg and 12.5mg, from the US Food and Drugs Administration (FDA). Lupin’s wholly owned US subsidiary Lupin Pharmaceuticals Inc (LPI) shall commence marketing the product shortly.


Lupin’s Zolpidem CR tablets 6.25 mg & 12.5 mg is the AB rated generic equivalent of Sanofi’s Ambien CR extended-release tablets and is indicated for the treatment of insomnia characterized by difficulties with sleep onset or sleep maintenance.

Sanofi’s Ambien CR extended-release tablets had annual US sales of about $ 366 million  as per IMS MAT March 2013 data.

User

BSE, S&P Dow Jones set up JV for providing indices

Asia Index, the JV between BSE and S&P Dow Jones aims to an array of indices enabling global and domestic investors to participate in South Asia’s vibrant economies

The BSE (erstwhile Bombay Stock Exchange) and S&P Dow Jones have formed a joint venture, 'Asia Index' to provide an array of indices enabling global and domestic investors to participate in South Asia’s vibrant economies.

 

In a statement, the Exchange said, “BSE and S&P Dow Jones Indices announced today the incorporation of Asia Index Pvt Ltd, a joint venture company established to calculate, disseminate, and license the widely followed suite of S&P BSE indices”.

 

The 50-50 partnership would bring together BSE’s closely watched India index suite, which includes the 30-share Sensex, with S&P Dow Jones Indices’ 115 years of experience in publishing transparent and independent global benchmarks.

 

“It (Asia Index) will bring additional focus to our efforts to serve investors and develop new business in an area of tremendous potential in India and the entire South Asia geography,” Ashishkumar Chauhan, managing director and chief executive of BSE said.

 

Asia Index aims to provide a full array of indices enabling global and domestic investors to participate in South Asia’s vibrant economies. It would help investors in achieving their financial goals.

 

“India, as well as all of South Asia and the ASEAN region, is a market of great strategic importance to S&P Dow Jones Indices. We are excited about the launch of Asia Index and look forward to working closely with the BSE to meet the increasing demand of this critical market segment,” Asia Index CEO Alka Banerjee said.

 

In February, the BSE and S&P Dow Jones Indices had announced a partnership to meet the evolving needs of Indian and international investors through the development of innovative index solutions.

User

RTI Judgement Series: Citizens have the right to know about irregularities in banks

If there are certain irregularities in the working and functioning of banks and institutions, the citizens certainly have a right to know about the same, the CIC said. This is the 174th in a series of important judgements given by former Central Information Commissioner Shailesh Gandhi that can be used or quoted in an RTI application

The Central Information Commission (CIC), while allowing an appeal, directed the Central Public Information Officer (CPIO) and chief general manager (CGM) of National Bank for Agriculture and Rural Development (NABARD) to provide copies of inspection reports of apex co-operative banks. The CPIO had denied the information citing exemption under Section 8(1)(a) of the Right to Information (RTI) Act.

 

While giving the judgement on 14 November 2011, Shailesh Gandhi, the then Central Information Commissioner said, "...this Bench is of the considered opinion that even if the information sought in query 1 was exempted under Section 8(1)(a) of the RTI Act, as claimed by the PIO, Section 8(2) of the RTI Act would mandate disclosure of the information."

 

Mumbai resident Kishanlal Mittal, on 12 May 2011, sought from the PIO information regarding inspection reports of apex co-operative bank in Maharashtra. Here is the information he sought and the reply provided by the PIO under the RTI Act...

 

1. Kindly provide copies of inspection reports of apex co-operative banks of various states/Mumbai District Co-operative Bank from 2005 till date.

PIO's reply—Furnishing of information is exempt under See 8(1)(a) of the RTI Act

 

2. Kindly provide copies of all correspondences with Maharashtra State Govt/RBI/any other agency of State/Central government regarding Maharashtra State Cooperative bank from January 2010 till date.

PIO's reply—Different departments in NABARD deal with various issues related to MSCB. The query is general in nature. Applicant may please be specific in query / information sought

 

3. Kindly provide confirmed/draft minutes of meetings of governing board/board of directors / committee of directors of NABARD from April 2007 till date.

PIO's reply—Furnishing of information is exempt under Sec 8(1) (d) of the RTI Act

 

4. Kindly provide information on compliance of section 4 of RTI Act, 2005 by NABARD.

PIO's reply—Compliance available on the web site of NABARD (i.e.www.nabard.org)

 

5. Kindly provide the above information on a CD.

PIO's reply—NIL

 

Citing unsatisfactory information given by the PIO, the appellant filed his first appeal, in which he stated that for query 2, inspection should have been offered (by the PIO).

 

There was no mention of any order passed by First Appellate Authority (FAA).

 

Mittal, the appellant then approached the CIC with his second appeal.

 

During the hearing, the PIO stated that he had provided information after the order of the FAA on query-3. Mittal, the appellant contended that he had not been given copies of the various notes which have been referred to in the minutes of the meeting. The PIO stated he was willing to provide these if the appellant explains which papers he is referring to.

 

As regards query-1 the PIO claimed exemption under Section 8(1)(a) of the RTI Act. Mr Gandhi, the then CIC said, the Bench would examine the exemption claimed by the PIO under Section (8)(1)(a) for query 1.

 

Section 8(1)(a) of the RTI Act exempts "information, disclosure of which would prejudicially affect the sovereignty and integrity of India, the security, strategic, scientific or economic interests of the State, relation with foreign State or lead to incitement of an offence".

 

The Bench said, "From a plain reading of the said provision, it is unlikely that disclosure of the information sought in query 1 would prejudicially affect the sovereignty and integrity of India, the security, strategic or scientific interests of the State, or relation with a foreign state or lead to incitement of an offence. Therefore, the issue to be examined is whether disclosure of the information sought in query 1 is likely to prejudicially affect the economic interests of the state."

 

"In query 1, the appellant has sought copies of inspection reports of apex co-operative banks of various states/ Mumbai District Co-operative Bank from 2005 till date. At the outset," Mr Gandhi said, "this Bench is unable to agree with the PIO that disclosing the said inspection report(s) would prejudicially affect the economic interests of the Indian nation. Moreover, even if the information sought was exempt under Section 8(1)(a) of the RTI Act, this Bench is of the considered view that disclosure of inspection reports of apex co-operative banks of various states/ Mumbai District Co-operative Bank must be shared with the public in a proactive manner. This kind of disclosure would certainly serve public interest, as mandated under Section 8(2) of the RTI Act."

 

Section 8(2) of the RTI Act states, "Notwithstanding anything in the Official Secrets Act, 1923 nor any of the exemptions permissible in accordance with sub-section (1), a public authority may allow access to information, if public interests in disclosure outweighs the harm to the protected interests".

 

Mr Gandhi said, "It is pertinent to mention that significant amounts of public funds are kept with institutions including co-operative banks which are regulated by the apex co-operative banks. Therefore, it is only logical that the public has a right to know about the functioning and working of such entities including any lapses in regulatory compliances. Merely because disclosure of such information may harm the economic interest of the state, that cannot be a reason for denial of information under the RTI Act. If there are certain irregularities in the working and functioning of such banks and institutions, the citizens certainly have a right to know about the same. The best check on arbitrariness, mistakes and corruption is transparency, which allows thousands of citizens to act as monitors of public interest. There must be transparency as regards such organisations so that citizens can make an informed choice about them."

 

The CIC cited a clarion call in State of Uttar Pradesh vs Raj Narain (1975) 4 SCC 428, by Justice Mathew that stated...

 

"In a government of responsibility like ours, where all the agents of the public must be responsible for their conduct, there can be but few secrets. The people of this country have a right to know every public act, everything that is done in a public way by their public functionaries. They are entitled to know the particulars of every public transaction in all its bearing. Their right to know, which is derived from the concept of freedom of speech, though not absolute, is a factor which should make one wary when secrecy is claimed for transactions which can at any rate have no repercussion on public security".

 

The Bench also cited observations of the Supreme Court in SP Gupta vs President of India & Ors (AIR 1982 SC 149).

 

"It is axiomatic that every action of the government must be actuated by public interest but even so we find cases, though not many, where governmental action is taken not for public good but for personal gain or other extraneous considerations. Sometimes governmental action is influenced by political and other motivations and pressures…

 

At times, there are also instances of misuse or abuse of authority on the part of the executive. Now, if secrecy were to be observed in the functioning of government and the processes of government were to be kept hidden from public scrutiny, it would tend to promote and encourage oppression, corruption and misuse or abuse of authority, for it would all be shrouded in the veil of secrecy without any public accountability. But if there is an open government with means, of information available to the public there would be greater exposure of the functioning of government and it would help to assure the people a better and more efficient administration. There can be little doubt that' exposure to public gaze and scrutiny is one of the surest means of achieving a clean and healthy administration. It has been truly said that an open government is clean government and a powerful safeguard against political and administrative aberration and inefficiency…

 

This is the new democratic culture of an open society towards which every liberal democracy is evolving and our country should be no exception. The concept of an open government is the direct emanation from the right to know which seems to be implicit in the right of free speech and expression guaranteed under Article 19(1)(a). Therefore, disclosure of information in regard to the functioning of Government must be the rule and secrecy an exception justified only where the strictest requirement of public interest so demands...

 

Even though the head of the department or even the Minister may file an affidavit claiming immunity from disclosure of certain unofficial documents in the public interest, it is well settled that the court has residual powers to nevertheless call for the documents and examine them. The court is not bound by the statement made by the minister or the head of the department in the affidavit. While the head of the department concerned was competent to make a judgment on whether the disclosure of unpublished official records would harm the nation or the public service, he/she is not competent to decide what was in the public interest as that it the job of the courts. The court retains the power to balance the injury to the State or the public service against the risk of injustice, before reaching its decision on whether to disclose the document publicly or not."

 

Mr Gandhi said, "The idea that citizens are not mature enough to understand and will panic is repugnant to democracy. The exemptions under Section 8 and 9 of the RTI Act are the constraints put by Parliament and adjudicating bodies have to carefully consider whether the exemptions apply before denying any information under the RTI framework."  

 

While allowing the appeal, the Bench directed the PIO to give information to Mittal with regard to query 1 before 10 December 2011.

 

CENTRAL INFORMATION COMMISSION

 

Decision No. CIC/SG/A/2011/002793/15661

http://www.rti.india.gov.in/cic_decisions/CIC_SG_A_2011_002793_15661_M_70346.pdf

Appeal No. CIC/SG/A/2011/002793

 

Appellant                                            : Kishanlal Mittal

                                                            Mumbai - 400066

 

Respondent                                        : P Satish

                                                            CPIO & Chief General Manager

                                                            NABARD,

                                                            Head Office, Plot:C-24/'G',

                                                           Bandra-Kurla Complex,

                                                            Post Box-8121, Bandra (East),

                                                            Mumbai-400051

 

 

User

We are listening!

Solve the equation and enter in the Captcha field.
  Loading...
Close

To continue


Please
Sign Up or Sign In
with

Email
Close

To continue


Please
Sign Up or Sign In
with

Email

BUY NOW

The Scam
24 Year Of The Scam: The Perennial Bestseller, reads like a Thriller!
Moneylife Magazine
Fiercely independent and pro-consumer information on personal finance
Stockletters in 3 Flavours
Outstanding research that beats mutual funds year after year
MAS: Complete Online Financial Advisory
(Includes Moneylife Magazine and Lion Stockletter)