No Remedy

India lacks an effective drug recall system

There have been very few recalls of domestic drugs in India, particularly when compared to the number of recalls of Indian drugs in Western markets. danish siddiqui / reuters
01 June, 2016

Last May, the Indian pharmaceutical firm Cipla recalled about 140,000 vials of levalbuterol solution, used to relieve shortness of breath and coughing, from the US market. In mid July, also in the United States, another major Indian drug firm, Wockhardt, recalled over 162,000 cartons of various drugs used in the treatment of hypertension and ulcers. In September, the Canadian company Apotex recalled almost 118,000 bottles of cevimeline hydrochloride pills—used to treat dry mouth, especially in patients with an autoimmune disorder called Sjögren’s syndrome—manufactured by its Indian subsidiary. This, again, was in the United States. So, too, was a recall initiated this February by Sandoz, the generic-drugs division of the pharmaceutical giant Novartis, of 270,000 bottles of a hypertension drug manufactured for it by a firm in Hyderabad.

This is only a recent sampling, from just one country, of instances that form an unsettling pattern. For several years now, drugs of Indian manufacture have come under sharp scrutiny from regulators, particularly in the West, for failing to meet established standards. In 2015, the US Food and Drug Administration blacklisted the manufacturing sites of six Indian drug makers, and issued letters of warning to at least 15 companies manufacturing in India regarding unsatisfactory quality control and record-keeping. Reports of drugs made in India being recalled surface with glaring regularity. This threatens the credibility of the country’s pharmaceutical industry—which is valued at $18 billion, and currently supplies about a third of the generic drugs consumed in the United States, as well as about a quarter of those consumed in the United Kingdom.

But the rejection of these substandard medicines (also known as NSQ, or “not of standard quality,” drugs) in other countries points to an equally pressing concern: their fate in Indian markets. While spurious drugs, which contain little or no active ingredients, are widely recognised to be a problem in India, NSQ drugs, which contain some quantity of active pharmaceutical ingredients but do not meet dosage and quality standards, are less clearly defined or understood. But spurious drugs represent a far lower proportion of the faulty medicines in the Indian market than NSQ ones. According to one government report, spurious drugs comprised 0.17 percent of the pharmaceutical market between 2007 and 2008, while substandard drugs made up 6.3 percent of the market that year. A 2012 audit by the comptroller and auditor general, conducted in armed-forces medical stores, found that the share of domestically procured medicines that did not meet prescribed norms shot up from 15 percent between 2006 and 2007 to 31 percent between 2010 and 2011.

Yet when compared to the frequency of recalls of Indian drugs in Western markets—where a serious threat of penalties, prosecution and brand damage incentivises caution and swift action—very few domestic drugs have been recalled in India. A major reason for this is that the country has never dedicated sufficient resources to monitoring pharmaceutical standards and holding producers accountable, nor implemented cohesive laws at the national and state levels to govern the recall of NSQ drugs.

The bedrock of India’s present regime of pharmaceutical regulation is the Drugs and Cosmetics Act of 1940. The act divides functions between the centre and the state: it is only once the centre grants a drug approval to enter the Indian market that a particular state can license its manufacture and sale. This translates to a patchwork of 37 separate regulatory bodies nationwide: one for each of the 36 states and union territories, and the Central Drugs Standard Control Organisation, or CDSCO, operating from Delhi.

The resulting system is a mess of red tape and confusion, and, more often than not, acts to impede rather than ease regulatory action. For instance, a manufacturing licence for a drug in any particular state allows it to be sold across India, but authorities outside that state cannot suspend or cancel that licence if they find the drug defective, or even inspect the facility that manufactured it. Each authority can only initiate prosecution of an erring manufacturer within its own jurisdiction. For drugs manufactured elsewhere, it must notify the state where a defective drug is manufactured, and appeal to the authority in that state to act.

There are also no clear or uniform rules on how to recall NSQ drugs. Last year, Dinesh Thakur, a former employee of Ranbaxy who earlier blew the whistle on how the company was falsifying drug data and violating manufacturing standards, filed a series of Right to Information requests asking six states—Andhra Pradesh, Himachal Pradesh, Karnataka, Tamil Nadu, Uttarakhand and Maharashtra—to disclose their procedures for enforcing recalls. None besides Andhra Pradesh could point to any concrete regulations. Himachal Pradesh, Karnataka and Tamil Nadu pointed to either Schedule M of the Drugs and Cosmetics Act, or to guidelines passed under an amendment to the act in 2008. Neither the schedule nor the guidelines lay down specific procedures; rather, both direct the states to formulate standard recall procedures of their own.

The central government has made some effort to formulate norms that each state could consider for adoption, but progress on them has been slow. In October 2012, the CDSCO published draft guidelines for the recall of NSQ medicines, which the drug controller general of India, speaking to Express Pharma magazine, said he expected would start coming into force in the states in three or four months. That did not happen. The matter was still being discussed at a February 2013 meeting of the Drugs Consultative Committee, an advisory body, and at another meeting that November. Since then, there has been no further deliberation on it.

Any delay in creating firm rules to govern recalls causes untold damage to Indian patients. There has been no estimate of the number of people affected, but given India’s population, it certainly comes to many millions. Besides posing the obvious dangers to individual patients, NSQ medicines also contribute to larger problems such as increased drug resistance. This often occurs when patients take NSQ antibiotics that are weaker than advertised.

The current system is so ineffective that, more often than not, recalled drugs end up being consumed before they can be removed from circulation. The Drugs and Cosmetics Act has no provision mandating punishment for delay in recalling drugs that a company discovers to be NSQ, and manufacturers continue to evade liability for not taking prompt action. When manufacturers voluntarily recall a drug—as opposed to acting on recall orders from regulatory authorities—there is no mechanism for checking what quantity of the suspect drug is recovered. The lack of coordination and speed among individual state regulators has resulted in numerous cases where drugs declared NSQ in one state continue to be available in another.

Consider what Kerala’s deputy drug controller told the news portal Pharmabiz last year: “There is gigantic quantity of NSQ drugs in the Indian pharma market. They are marketed in several places by separate marketing companies. Most of these drugs are manufactured in the excise-free-zone areas in Uttarakhand and Himachal Pradesh. Those manufacturers should be accountable for withdrawing the batches immediately from the market. The state and central law-enforcing agencies are helpless in weeding out these batches from circulation or imposing any fine on the manufacturers due to lack of adequate provisions in the law.”

This situation is made even worse by a shortfall of essential personnel, which hampers the detection of NSQ drugs circulating in the market. Going by data submitted to the Rajya Sabha by the health ministry late last year, as of September there were only 1,467 drug inspectors in the entire country, against an estimated requirement of more than twice that number. And still, in states including Kerala, Himachal Pradesh and Bihar, drug inspectors continue to be diverted from their regular duties to help in tasks such as election work and disaster response. To make up for this crunch, the government has taken to recruiting inspectors on a contractual basis, even though doing so for gazetted positions is illegal. These contractual inspectors are poorly rewarded—according to a 2015 working paper by ICRIER, a Delhi-based think tank, one newly appointed inspector was receiving Rs 15,388 per month, “without any of the perks of permanent government service”—creating high incentives for corruption.

Added to this is a paucity of facilities, such as laboratories and vehicles. One former regulator from Kerala told ICRIER that, when heading out to inspect manufacturers, inspectors sometimes use transportation provided by the manufacturers themselves. An active official at a Bihar laboratory reported that the chronic lack of both manpower and equipment at his facility meant that samples often expired before they could be tested.

There are also massive discrepancies in the performance of individual state authorities. Statistics presented to the Lok Sabha by the health ministry this February describe a dismal picture. Over the 2015 financial year—the last for which complete data is available—drug authorities conducted a total of 14,042 raids across India (there were no raid figures reported for Karnataka). Over 8,000 of these occurred in Haryana alone, and only two other authorities reported conducting more than 1,000 raids each. Nineteen state authorities, including ones in large states such as Madhya Pradesh, conducted no raids at all.

The few violations that are detected rarely lead to prosecutions or arrests. The same statistics show that, of a total of 74,199 drug samples tested nationwide that year, 3,785 violated standards, which included spurious and NSQ drugs. The sum of prosecutions launched, however, was just 152, and that of related arrests just 85.

With regard to human resources and infrastructure, the onus for corrective action falls heavily on the central government. Back in 2012, the parliamentary standing committee on health and family welfare observed, “Given the lack of adequate resources in the States it would be unrealistic to expect them to improve the infrastructure and increase manpower without Central Assistance for strengthening drug control system.” But action has been lamentably slow. The committee directed the health ministry to create a “fully centrally sponsored scheme” to address the shortages. In December 2015, the ministry told the committee that the scheme had not been executed, as it was still awaiting the necessary approvals. The relevant department, it stated, “is pursuing the proposal.”