Supreme Court says clinical trials should be for our benefit, not for MNCs

The apex court said clinical trials in India must be to help the people and must not be allowed for the benefit of multinational companies-MNCs

While holding that the norms formulated by the Centre are 'deficient' in protecting  people’s rights, the Supreme Court has said that clinical trials in India must be to help the people and must not be allowed for the benefit of multinational companies (MNCs).


The apex court, while allowing trials for five entities, said no trial of new drugs will be allowed till the consent of people being subjected to the trial is recorded in audio/visual form. The SC also refused to pass an order on 157 drugs that were allowed by the Centre.


“The norms themselves are deficient and cannot ensure that untoward incidents do not take place. You (the Centre) should have a balanced approach and you cannot take a one-sided view. The regime must be fool-proof,” a bench headed by Justice RM Lodha said.


It ordered that clinical trials for the 157 drugs must be cleared by the technical and apex committees set up by the Centre for this purpose.


The court was hearing PILs filed by a doctor, Anand Rai, and an NGO, Swasthya Adhikar Manch, alleging large-scale clinical drug trials across the country by multinational pharmaceutical firms using Indian citizens as guinea-pigs. The Bench directed the committees to evaluate applications for clinical trials of drugs and take decisions by assessing the risk and benefit aspects and the people’s medical needs.


“In light of the above, it is not possible to pass an order regarding the 157 drugs. It can be considered only after the reports of the technical and apex committees are submitted,” the Bench said, adding, “With regard to five cases the trial is permitted.”


The Bench also said the government should appoint a panel of investigators to probe cases of clinical trials.


“How to ensure that the rights of people who are subjected to clinical trial are not jeopardised? What is the mechanism in place to protect their lives and avoid serious side-effects?” the Bench asked the Centre.


Additional Solicitor-General Siddharth Luthra submitted that the Centre is committed to putting in place a proper mechanism and the law has to be amended for the purpose; this is under consideration.


Karnataka government is encouraging iron ore production

Our indigenous production of iron ore is suffering badly, as exports have come to a standstill for a couple of years now

It may be recalled that the Supreme Court had permitted mining leases in category A and B mines in April this year. There were 45 mines in category A and 49 in B. In order to facilitate work to recommence the operations, the department of mining held individual meetings with the above category lessees in Karnataka.


While the mines in Karnataka in the above categories can commence their work, subject to compliance of required formalities, mines in Goa are still under the ban.


Out of the above, as many as 15 mines had commenced their operations and have mined about five million tonnes of iron ore, in addition to the production of National Mineral Development Corporation (NMDC).


NMDC has produced 12.89 million tonnes of iron, during April-September 2013, with Karnataka contributing 4.44 million tones and Chhattisgarh 8.45 million tonnes. In order to encourage production and supply of iron ore to starving steel mils and sponge iron producers, Karnataka state government sought approval from the Central Empowered Committee (CEC) to raise iron ore production of certain category A mines, as the Supreme Court has capped it at 30 million tonnes for the year. Actually, local requirements are estimated at 32-36 million tonnes. But, so far, production is down and is estimated at 21 million tonnes only.


Since the Supreme Court had cancelled all 51 mines in Category C, CEC is awaiting the reclamation and rehabilitation plans of category A and B mines, so that a final decision can be made.


Assuming a favourable order from CEC, production could reach only 25-26 million tonnes, leaving a shortfall of 4-5 million tonnes. This will affect the overall production, and any plans for export will have to be postponed for the time being.


The Department of Mines and Geology have also found that, typically, 70% of the iron ore mined is in lumps and only 30% are minimum fines. As such, most steel mills in the state have set up sintering plants and use only iron ore fines in blast furnaces. As a result, NMDC has an unsold stock of more than 2 million tonnes of lumps. They now have to either find the means to use them, or look out for an overseas buyer to export.


Among the leading players in the iron ore mining, Sesa Goa, now part of Sesa Sterlite, stopped mining two years ago, as per Supreme Court Directive. It has now secured the work permit from the Ministry of Environment and Forests (MOEF) to commence its operations in Chitradurga district. This permit is for only year only.


We wonder, why should this be so? Why can't the permit be given to be valid, say, for 3 years or more, if necessary with some periodic inspection? Work in mines should be continuous and can not be subject to interruptions. Final approval from the monitoring committee to resume operations is awaited.


Sesa Goa has the mining capacity of 2.3 million tonnes per year. Fortunately, the MOEF has given the lease for 20 years. In the meantime, the Karnataka forest department has raised a claim for development tax based on invoice value of exports effected by them during 2008-11.They have stated that they would issue a no objection certificate (NOC) only after receiving this payment! In return, the company has disputed this claim asserting that the tax assessment should be valued at "ex-mines" and not based on export invoice.


This impasse has to be resolved urgently and Karnataka forest department should not prevent the work, as this will be detrimental to national interest. We need to bear in mind that our indigenous production is suffering badly as exports have come to a standstill for a couple of years now. Our regular buyers can not afford to "wait" for Indian iron ore supplies and we have to regain these "lost" markets.


(AK Ramdas has worked with the Engineering Export Promotion Council of the ministry of commerce. He was also associated with various committees of the Council. His international career took him to places like Beirut, Kuwait and Dubai at a time when these were small trading outposts; and later to the US.)


UltraTech Cement Q2 net profit tumbles 52% as outlook remains challenging

Slowdown in infrastructure and household projects results in decrease in profit for the country’s largest cement manufacturer during the September quarter

UltraTech Cement Ltd, India’s largest cement manufacturer, reported a 52% fall in its September quarter net profit on sluggish demand coupled with rising input and energy costs. The Aditya Birla group company said it expects the outlook to remain challenging during FY14.


For the quarter to end-September, the cement maker said its net profit fell to Rs264.1 crore from Rs550 crore while its total revenues from operations declined 4.3% to Rs4521.9 crore from Rs4729.4 crore, same period last year.


"The outlook continues to remain challenging. Demand growth in FY14 is likely to be around 5%, though in the long term growth is likely to be over 8%," UltraTech said in a release.


During the second quarter, the cement producer’s total expenses, including a sharp increase in employee benefit expense and depreciation and amortisation, increased to Rs4,099.7 crore from Rs3,926.7 crore in September 2012 quarter.


At 11.15am Tuesday, UltraTech Cement was trading marginally down at Rs1944.7 on the BSE, while the benchmark Sensex was marginally up at 20,916.


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