India gets tough on generics quality issues and cancer drug prices

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Even as more blood pressure drugs are being recalled in the USA after being found to contain trace amounts of a potentially cancer-causing ingredient, India’s drug controller is putting stringent quality control measures in place aiming to boost public confidence in generic medicines, reports The Pharma Letter’s India correspondent. As part of the move, generic drug manufacturers in India will now have to prove quality and safety equivalence with a reference product that has already been tested by the regulator. A health ministry official explained: “It is part of the data collected under the bioavailability and bioequivalence study, wherein the reference product or the first brand will be given by the drug controller to be duly tested.” The onus will then lie on the generic manufacturer to prove that the quality of their drug is similar to the branded one, the official added. Cracking the whip on drug companies, the Indian government is asking them to get in line over quality issues.
The move assumes significance with the US Food and Drug Administration recently weighing in on the recalls of multiple generic angiotensin II receptor blockers.

Drug recalls 
Indian drug companies have been recalling their medicines for some time now. On February 28, Torrent Pharmaceuticals said it is recalling 229,896 bottles of tablets used for the treatment of high blood pressure from the US and Puerto Rico, on account of deviations from the current Good Manufacturing norms. The same day, Aurobindo Pharma initiated a voluntary nationwide recall of 38 lots of valsartan and amlodipine and valsartan tablets to a recall that started with 80 lots end-December, due to the detection of N-nitrosodiethylamine (NDEA) impurity. The impurity detected in the finished drug product is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer classification, according to a company statement.

The US FDA has also found cancer-causing toxin in Hetero’s blood pressure drug. In January, it warned of the possibility of additional shortages of hypertension drugs in the USA due to the many recalls. End-December, drug major Mylan said it was voluntarily recalling over 1.2 million bottles of three anti-hypertension drugs of different count from the US market due to the presence of NDEA. According to the notification by the US FDA, valsartan, the active pharma ingredient in all the three drugs, amlodipine and valsartan, valsartan and hydrochlorothiazide, was manufactured by Mylan at its Nashik plant, near Maharashtra.

It may be recalled that Hyderabad-based drug major Aurobindo has been named in a class action lawsuit in the USA for contamination of its irbesartan active pharma ingredient (API) used in the treatment of high blood pressure. The lawsuit was filed in the Federal Court of Florida against Aurobindo Pharma end-December, and also USA-based pharma company ScieGen Pharmaceuticals, which used Aurobindo’s irbesartan API to make its blood pressure lowering product, besides the distributor Westminster Pharmaceuticals and the US retail supply chain Walmart. The lawsuit is a part of growing litigation against the makers and distributors of sartan-based blood pressure lowering drugs in the USA.Earlier, the European Medicines Agency announced that it had started reviewing medicines with valsartan ingredient supplied by Chinese company Zhejiang Huahai Pharma, which is currently facing similar lawsuits in the USA.

Cheaper cancer drugs
Back in India, the laws are getting stricter. Apart from having to prove quality and safety equivalence for generic medicines, the national drug price regulator has also upped its ante on anticancer drugs. The National Pharmaceutical Pricing Authority (NPPA) has invoked Para 19 of the Drugs and Cosmetics Act 2013 and brought 42 anti-cancer drugs under price control. Prices will be down by at least 30% with the drug pricing watchdog capping trade margins. The government cited high out-of-pocket expenditure for cancer hospitalization, which is almost 2.5 times higher than overall average hospitalization expenditure, for invoking Para 19 of the Act.
“The cost of 42 life-saving cancer drugs, which are available in 72 different formulations and 355 brands, are all set to drop over the coming months. Capping of trade margins should bring relief to cancer patients,” said a healthcare official.
Senior cancer specialist Dr P Raghuram said cancer drugs are unique because they are administered in cycles and patients take drugs on multiple occasions.
Senior clinical oncologist at the MNK Cancer Hospital, Dr C Sairam termed it a first major step by the government to bring in control over highly expensive cancer drugs in the country. Some of the drugs in the NPPA list are Lapatinib (breast cancer); Lomustin (brain tumor); Nilotinib (leukemias); Azacitidine (blood and bone marrow); Erubulin (breast cancer); Cytarabine (te leukemia); Ribiciclib (breast cancer), Lenalidomide (bone marrow); clofarabine (blood cancer); and Mitomycin (stomach cancer).

Cost of cancer treatment across all cancer types are high with advanced therapy costing about $14,097 for locally advanced stage (stages two and three) and over $197,353 for the metastatic stage. The financial burden associated with cancer can force patients and households to acute misery and even insolvency. A recent Edelweiss Tokio Life Insurance study had estimated that 33% patients with metastatic cancer discontinue treatment due to high costs. “It is estimated that more than 50% cancer patients avail private sector facilities and out-of-pocket expenses in health care,” the NPPA said. NPPA has quoted the Competition Commission of India’s policy note ‘Making Market Work for Affordable Healthcare’ that had observed the information asymmetry in the pharma sector and supplier-induced demand that significantly circumscribes consumer choice. One major factor contributing to high drug prices has been the unreasonable high trade margin, and the NPPA circular cites a report which notes trade margin allowed to retailers tend to go up to even 1800% or more.
Source : thepharmaletter

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