Pharma Regulations

Source: The Hitavada      Date: 06 Dec 2017 12:12:37

By Nantoo banerjee,

One wonders that if the Indian firms can take risks like having unclean manufacturing units, while being subjected to frequently conducted inspections by the regulatory authorities in the US and EU, what kind of practices they may be following in India,in the near absence of regulatory pressure on production procedures and product quality. Are the foreign rejects sold in the Indian market?

Almost 50 per cent of India’s Rs. 2.20-lakh-crore annual revenue of the pharmaceutical industry comes from exports. They are under constant regulatory control in the US and Europe on quality, production procedure, packaging and price. The producers can’t grumble. Either they fall in line, or lose their profitable exports. Under pressure, they are forced to produce quality medicines, including injectables, follow production procedures and safety norms and meet the pricing pressure.

One wonders why the Indian regulatory authorities are so little concerned about the quality of drugs the country’s same pharmaceutical firms produce, procedures they follow and massive Post-Manufacturing Expenses (PMEs) they load in Maximum Retail Price (MRP) of drugs, including marketing through medical practitioners, private clinics and hospitals? Although India’s Drug Price Control Authority (DPCA) is doing a good job by periodically cutting down prices of scheduled essential drugs and medical devices such as stents, orthopaedic implants, etc, they seem to have little impact on the pockets of patients as the drug or implant administrators invariably raise prices of other attendant procedures and services in the absence of any pressure from concerned Central and State regulatory authorities.

Few Indian drug exporters to the US find it easy to sell their products in that market. Almost all well-known Indian drug firms such as Glenmark, Dr. Reddy’s Lab, Sun Pharma, Lupin, Cipla, Aurobindo, Divis, Cadila and Torrent, to name a few, had tormenting experience in dealing with the inspection and quality regimes of the US Food and Drug Administration (USFDA). The Indian media comes to know about the issues and market recalls from the USFDA website and mandatory stock exchange notification by listed companies. For instance, USFDA found deficiencies in manufacturing practices at Glenmark’s plant in Baddi. Recently, it issued as many as seven adverse observations (known as Form 483) after an audit.

The firm makes dermatology products that contribute around 10 per cent of its US sales. During April-September, 2017, Glenmark earned Rs 1,772 crore in revenue from the US market, represented 38 per cent of its total revenue. The firm has around 70 products pending for approval in the US and five of them have been filed from Baddi. Adverse observations to the manufacturing unit can delay product approvals and impact sales. “We are in the midst of providing a comprehensive response to the observations and would be replying to the FDA shortly,” Glenmark said in a stock exchange notification. Similarly, Sun Pharma’s US subsidiary voluntarily recalled two lots of its diabetes drug ‘Riomet’ due to microbial contamination.

Riomet is indicated to treat type-2 diabetes mellitus in adults and children over 10 years old. The product is manufactured by a contract manufacturer, stated Sun Pharma in a press release. This is one of several voluntary recalls that the firm has carried out this year for different products, according to USFDA reports.

In another instance, the USFDA warned Lupin on repeated quality control violations. Lupin makes generic antibiotics, antidepressants and heart medications for sale in the US. The FDA tests showed that pills made at two of its facilities didn’t meet quality standards. In 2015 and 2016, the FDA found 134 instances when drugs or active ingredients failed initial testing but the company chose to override the results. Lupin called the failed tests at the plant a “laboratory error” even when evidence suggested that that wasn’t the case.

In Europe, a German drug regulating agency, which audited one of Dr. Reddy’s Laboratories manufacturing facilities, found “dirty rooms and equipment”, among other violations. The Central Authority for Supervision of Medicinal Products in Bavaria (GMP/GCP) conducted the inspection on August 1 at the drug maker’s formulation manufacturing unit-2 at Bachupally. “Pending revocation of the non-compliance certification, the plant will not be able to make any further dispatches to European Union until the next inspection, to be initiated by an invitation from Betapharm,” Dr. Reddy’s was informed. Recently, Dr. Reddy’s initiated a nation-wide recall of over half a million bottles of Famotidine tablets, 10 mg, in the US after the drug failed impurities/degradation specifications in routine stability testing, said USFDA.

One wonders if these Indian firms can take such risks against frequently conducted inspections by the regulatory authorities in the US and EU. What kind of practices they may be following in India in the near absence of regulatory pressure on production procedures and product quality? Are the foreign rejects sold in the Indian market? Last week, a WHO report said that about 10.5 per cent drugs are substandard and spurious in India. Unfortunately, a hospital-doctor-drug firm-inspector nexus in the country appears to be too cosy to have any adverse impact on careless manufacturers.

The Indian drug industry may be taking it easy on local consumers in the absence of serious concerns from the Government and drug administrators. According to India’s Drug Controller General (DGCI) G. N. Singh, “substandard medicines are a major issue in India and we are looking out for ways to tackle the problem. As quality regulator, we are developing proper mechanisms to stop manufacture and sale of counterfeit drugs so that they don’t reach the patients.”

The existing Drugs and Cosmetics Rules, 1945, is proposed to be amended to make “stability testing” mandatory for all drugs sold in India. “Stability testing will be made compulsory for all the drugs. An advisory letter has already been sent to State drug controllers and a notification amending the rules is likely to come soon,” said the DCGI. Once the new rules take effect, drug firms will have to subject their products to quality tests to make sure that drugs do not lose their potency and expiry dates printed on the packaging are based on the test results. Not many are hopeful that the amendment of the rules will make much change in the ways of India’s drug manufacturers.