Asia Regulatory Roundup: The Curious Case of India's Fixed-Dose Drugs (10 February 2015)

Regulatory NewsRegulatory News | 10 February 2015 |  By 

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Lancet: Legislation Allows Harmful FDCs to Bypass CDSCO Oversight

A paper in The Lancet has warned that manufacturers are using fixed-dose combinations (FDC) as a way to bypass regulatory oversight and price controls in India. More than 40 metformin FDCs are approved by the Central Drugs Standard Control Organization (CDSCO) for diabetes — and 500 brands are sold in the country — despite doubts about their effectiveness.

Metformin FDCs outsell single-drug formulations by three to one, The Times of India reports, but are almost exclusively sold in India. Just one metformin FDC is available overseas. The Lancet analysis failed to find convincing evidence to support the use of FDCs. CDSCO has released no information about why it approved the drugs and no data on studies of the products are found in the clinical trial registry.

The information the researchers did manage to find raised concerns. Many FDCs were reportedly studied in short trials that failed to show the products met World Health Organization standards for safety and efficacy. Researchers have called for CDSCO to share the data that guided its approvals of metformin FDCs and for legislators to rework the drug act to prevent drugs of questionable benefit being sold.

“Many such dubious drug combinations should be banned, and taken off the market. Strict criteria and testing should be applied to screen any new FDC, and also background and past performance of manufacturing company should be strictly monitored,” Dr. Anoop Misra, chairman of the Fortis CDOC diabetes hospital, said.

The Times of India

India Moves to Extend Track and Trace to Primary Packaging

The Indian government plans to extend track and trace requirements to cover the primary packaging of products sold domestically, The Times of India reports. Currently, manufacturers are only required to tag the secondary and tertiary packaging of drugs intended for export.

An official launch of the policy is due to take place within the next few years, but details have already leaked out. The plan is to add authentication codes to primary packaging, such as vials and blister packs. “The consumer will be able to check the genuineness of the medicine by feeding the unique identification code on a central portal developed by the ministry and later track it even through a mobile phone,” an official said.

Manufacturers are concerned about the plan. When India adopted track and trace for exports to counter claims local firms were sending counterfeit medicines to Africa, manufacturers said the tagging of primary packaging would be too expensive and cumbersome. The challenge on a domestic level is magnified by the scale of the market, which includes 60,000 formulations.

The Times of India’s source said the government will attempt to offset the industry’s financial worries by bearing a major part of the costs and providing the software.

The Times of India

New DRAP Chief Makes Breakthrough in Pricing Talks

The new head of the Drug Regulatory Authority of Pakistan (DRAP) has made an immediate impact, according to news reports. Within days of taking the role, Dr. Mohammed Aslam, DRAP's new head, met with industry leaders and persuaded them to drop their opposition to pricing policy proposed by the regulator.

Industry officials reportedly backed down after receiving assurances from the government, including an agreement to automatically adjust prices whenever the Consumer Price Index (CPI) changes. The linking of prices to CPI — which is expected to ensure profit margins for manufacturers — is due to come into force in July 2016.

Some concessions came too late for DRAP to change the policy before it went to the Economic Coordination Committee for approval. “We have decided to let the government clear the policy draft with an understanding that the two parties — the government and the industry — will continue to engage in talks even after the approval of the policy,” an industry official told The Express Tribune.

The compromise follows two years in which the industry and government struggled to find common ground. Having made the breakthrough, industry officials are eyeing further changes to DRAP. The government has been criticized for prioritizing pricing over quality control — the industry claims DRAP has 14 inspectors for 600 plants — and enacting export-stifling policies.

The Express TribuneI The News I More

CDSCO Preparing Standards for Online Pharmacies

CDSCO is preparing standards covering the online sale of medicines, PharmaBiz reports. India’s national advisor for drugs control, Dr. BR Jagashetty, is leading the initiative as part of his brief to improve the IT capabilities of CDSCO and the industry.

Jagashetty expects the standards to mandate the use of doctors’ registration numbers and other details in online drug sales. The requirements would increase regulatory control over online pharmacies, which have opened and grown despite a lack of laws specifically for their operation. Jagashetty said a new set of laws is needed.

Some regulators have already taken action against illegal online pharmacies — the Maharashtra Food and Drugs Administration raided 27 establishments in April — but the lack of an overarching policy means enforcement is patchy.


Other News:

The China Food and Drug Administration (CFDA) has released a list of nine online drug retailers accused of publishing misleading information. CFDA made similar allegations against 10 other websites in November. The clampdown comes as China prepares to allow pharmacies to sell prescription drugs online. CFDA Notice (Chinese)

A US Food and Drug Administration (FDA) official has said Indian regulators should always be invited to attend inspections of local production plants. However, while the policy is to offer Indian inspectors the chance to accompany FDA staffers, the official admitted “there might be some glitches.” The comments follow complaints by Indian trade group Pharmexcil about unannounced visits. The Hindu

BioCentury has taken a look at the possible priorities of CFDA’s new leader. As previously reported, many expect drug pricing reform to occupy a lot of Bi Jingquan’s time. Others see the appointment of someone with strong government connections as an indication of a desire to accelerate the reform of CFDA and the healthcare sector. Bi’s age suggests he may only hold office for a short time. BioCentury

India is reportedly considering reevaluating its approach to data protection and patent linkage. The proposed changes would mean generics manufacturers would pose less of a threat to innovative pharma companies. India intends to achieve this outcome initially by telling direct central and state drug controllers to change their approach, although new laws could follow. The Financial Express

CFDA has ordered a clampdown on herbal medicines. The regulator took the action after discovering widespread quality and safety issues, despite earlier attempts to improve the situation. Officials intend to severely punish criminal acts, take steps to improve product quality and coordinate their management and inspection activities. CFDA Notice (Chinese)

CDSCO has put state authorities on high alert after oxytocin injections were seized from an unlicensed store. The retail sale of oxytocin — which is misused in India in multiple ways — was banned last year. Despite the ban and a policy of only allowing licensed producers to source the active ingredient, the product is still available. India Today

CFDA has invited the head of Shandong Qidu Pharmaceutical for a talk after the company began a huge recall of levofloxacin hydrochloride and sodium chloride. The manufacturer has recalled 21,700 bottles of the products after “impurities similar to furs” were found and admitted its negligence. Press Trust of India


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