The USFDA’s presence in India is being increased to 19 from 12 American staff based in-country, including 10 dedicated specifically to medical products
The US Food and Drug Administration (USFDA) is increasing its inspections of facilities of drug makers in India, the second largest provider of finished dose products to the US, to ensure compliance of approved manufacturing norms.
The US health regulator, which has been cracking the whip against many Indian pharmaceutical companies, including Ranbaxy Laboratories and Wockhardt, is also recruiting and training additional drugs investigators in India.
The FDA said it is stepping up inspections in India in order to meet the requirements of the new Food and Drug Administration Safety and Innovation Act (FDASIA) — Generic Drug User Fee Amendments (GDUFA).
“In March 2013 the (US) FDA received approval from the Indian Government to add seven additional drugs investigators in India.
The USFDA’s presence in India is being increased to 19 from 12 American staff based in-country, including 10 dedicated specifically to medical products. Other staff include foods and devices inspectors, and policy analysts.
“Having these additional inspectors in-country will assist the agency in meeting our legislative mandates. So we are increasing our rates of inspection,” Kelly added.
Under the FDASIA, the USFDA is required to achieve the same inspectional schedule for foreign facilities as domestic manufacturers, and to clear the backlog of applications by the end of the first five-year user fee authorisation period.
India, as the second largest provider of finished dose products to the US with almost 10 per cent of that market, has, for many years, been a consistent provider of low-cost and quality medical products for many countries of the world.
According to the independent MP, brute force methods involving significant additional spending and increase in costs to consumers would not help financial inclusion and the government must relook at the RBI proposal on Aadhaar authenticated biometric ATMs
Rajeev Chandrasekhar, an independent member of the Rajya Sabha, who is also a member of the Standing Committee on Finance, has requested Prime Minister Manmohan Singh to relook at the Reserve Bank of India (RBI)'s proposal on Aadhaar authenticated biometric automated teller machines (ATMs).
In the letter sent to the PM, finance minister P Chidambaram and chairman of Standing Committee on Finance, Mr Chandrasekhar wrote, "Public policy towards financial inclusion should be devised intelligently with objective of lower banking costs and increased access for consumers and not using ill-conceived, brute force methods involving significant additional spending and increase in costs to consumers and please make no mistake, these costs will be passed on by banks to consumers."
Moneylife has been pointing out that this new directive (from RBI) will involve additional expenses, which bank depositors will end up bearing under the guise of technology costs. So far, Aadhaar has made no mention of who will bear the cost of biometric POS (point of sale) readers (according to a senior banker, they will cost Rs8,000 each) and biometric ATMs (Rs4 lakh for the machine plus installation, maintenance, electricity, etc). According to the news report, banks are expected to add around 200,000 POS machines and around 20,000 ATMs next year.
While Aadhaar-based authentication is touted as the panacea for financial inclusion of illiterate masses, it has not worked. Between 2004 and 2007, several banks launched biometric ATMs, with much fanfare, around the country. They did not work and had to be quietly discarded. Before embarking on another financial misadventure, the government needs to prove that there is better technology, which will work, especially since RBI’s internal committees have expressed several misgivings about the technology.
Here is the letter sent by the MP...
Damyanti Vithalani, a Moneylife reader got her money back from Yash Birla group companies by filing a complaint to MCA portal. Those who invested in the corporate FDs of Zenith Birla (India) and Birla Power Solutions can follow her tactic to get their money back
Moneylife has received several complaints from agitated readers and senior citizens who have not been able tot get their fixed deposit (FD) maturity amounts from Yash Birla Group companies – Zenith Birla (India) Ltd and Birla Power Solutions. Damyanti Vithalani, who fought for her refund says that a complaint to the Ministry of Company Affairs (MCA) website reached the right ears. Here is what you need to do to get your money back from the Yash Birla group companies.
Ms Vithlani managed to get her money back after filing complaints with the MCA as well as the CLB. She had invested in corporate FD of Zenith Birla India Ltd. On maturity, the company received her FD claim but they did not give any timeline for refunding the money. Later on, she filed complaint on MCA website and wrote emails to the legal team of Yash Birla group as well as the company’s board members, PVR Murthy and Vimal Dubey. She sent a copy of every email to MCA at [email protected] and Ministry of Commerce (MoC). She also filed her complaint with the CLB. After following this process for a month, she received Rs6 lakh from Zenith Birla India.
Between March and June 2013, the CLB had received as many as 130 complaints against other Yash Birla group company, Birla Power Solutions. Applicants have filed complaints under section 58A(9) of the Companies Act, 1956 as the company has failed to repay their deposits-FDs as per the terms and conditions of acceptance of deposits.
On 30 August 2013, in view of the genuine claim of the applicants and also in exercise of powers conferred under section 58A (9) of the Companies Act, 1956, CLB Member Vimla Yadav directed Birla Power, as under:
As of March 2012, Yash Birla group companies owe Rs97.25 crore to small investors invested as fixed deposit. Birla Power Solutions owes the highest, Rs57.92 crore while Zenith Birla (India) owes Rs33.19 crore to FD holders. Birla Cotsyn (India) and Shloka Infotech have collected FDs worth Rs5.67 crore and Rs52.84 lakh from investors as of March 2012. Yash Birla group companies have not yet published reports for end-March 2013.
Are Yash Birla Group companies in deep trouble? Yash Birla Group of companies has been struggling with many issues like liquidity crunch, non-payment of loans, negative cash flows etc. Most of its companies are giving negative returns to the investors and its share prices are not even in double digits.
Corporate FD’s are unsecured in nature but many investors including senior citizens like Damyanti Vithalani invested lakhs of rupees due to the goodwill of the Prestigious Birla Group. However, Yash Birla is more known for its lavish lifestyle on Page3 parties instead of his business moves, which shows the careless attitude of the group. The promoter’s stake in Birla Power Solutions is only 1.08%. It shows that the promoter himself lost faith in his company. For FY2013, Zenith Birla India reported a net loss of Rs44.62 crore while, during the June 2013 quarter it widened to Rs19.52 crore.