Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at email@example.com if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Our new book is a comprehensive look at a vital part of medicines development and regulatory affairs. Grab your copy today!
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
CDSCO Creates Induction Program to Raise Standards at Inspectorate
The Central Drugs Standard Control Organization (CDSCO) has set up an induction program to train assistant drug inspectors. A three-month training program, in which CDSCO will cover the regulatory framework in India and other topics, is the centerpiece of the induction strategy.
CDSCO has introduced the program to address what it sees as a gap between the potential of India as a pharmaceutical market and the skillsets of its regulatory officials. “It is considered that there is a huge gap in the regulatory science, practices and knowledge which needs to be bridged,” Drug Controller General of India GN Singh wrote in the introduction to the induction pack. “The skillsets possessed by our regulators need to be up scaled substantially.”
To achieve this objective, CDSCO has created a training program that is divided into four sections: technical and regulatory; legal and administrative; managerial and ethical; and communication and IT. The technical and regulatory component will give inspectors a grounding in the good practices that govern drug development, manufacturing and distribution, both in India and around the world. CDSCO will also explain the process for planning and conducting quality inspections and audits.
Graduates of the training program should emerge with legal knowledge to back up the regulatory learnings. Through these legal lessons, CDSCO wants to bring all inspectors up to speed with the Drugs and Cosmetics Act and other laws that cover the medical industry in India. Officials are looking to prepare inspectors for the evolution of IT at CDSCO, too. Part of Singh’s plan is to equip inspectors to effectively implement the incoming e-governance program at the regulator.
Induction Program, PharmaBiz
Pakistan Lowers Minimum Test Scores for new Hires After Candidates Fall Short
The Drugs Regulatory Authority of Pakistan (DRAP) has lowered the test score job applicants must achieve to be considered for employment. DRAP cut the qualifying criteria to 40% after too few of the applicants for a large number of positions achieved the old cutoff point of 50%.
Pakistan’s National Testing Service assessed candidates throughout July and August, culminating in the publication of a list of applicants who have met DRAP’s criteria this week. The posts being tested for ranged from the director of the pharmaceutical evaluation, drug licensing and quality assurance divisions down to data entry operator. Yet despite the breadth of positions being recruited for, each set of tests reached the same conclusion: Too few candidates are achieving an average mark of 50%.
The data entry operator positions attracted more than 750 applicants, 5% of whom scored 50% or higher on the tests. To give it the option to hire more than this subsection of applicants, DRAP has lowered the minimum score to 40%. In the data entry tests, this resulted in 16% of the applicants being eligible for employment. Similar trends were seen in senior positions. More than 80 people applied for the five director-level posts advertised by DRAP. Six people scored 50% or higher.
Sticking to the 50% acceptance criteria would have left DRAP without any applicants qualified to be director of the management information system division at a time when it is trying to strengthen its workforce. The tests are just one aspect of the strengthening process. DRAP is also looking to work with public relations companies and is revising the regulations that cover its employment policies. The revised regulations include a new section on the process for handling corrupt employees.
Recruitment Results, PR Statement, Regulatory Amendments
Staff Shortage at DRAP Prompts Pakistan to Exempt Alternative Medicines from Registration
Pakistan has temporarily exempted alternative medicines from certain requirements of the Drugs Act, 1976 because DRAP lacks the resources to cope with the workload enforcing the law entails. The action frees alternative medicine firms from the need to register products until the end of the year.
Sana ul Islam, a deputy secretary at the Ministry of National Health Services, alerted the industry to the change in a letter, in which the government exempted alternative medicines from section 7 of the Drugs Act, titled “registration of drugs.” The law states, “The federal government shall cause all drugs to be registered,” but this no longer applies to alternative medicines, temporarily at least.
Officials at the Pakistani government have made the exemption to free DRAP from the burden of registering alternative medicines. Islam wrote that DRAP “has received thousands of applications” from the producers, contract manufacturers and importers of alternative medicines at a time when it is “facing human resource and capacity issues.” With DRAP seemingly lacking the resources to carry out all of its tasks, the question is which tasks it can drop without creating public health risks.
The government has sought to cut the danger of the registration exemption creating such risks by using the letter to remind alternative medicine manufacturers of their responsibilities. Islam told the firms they must take responsibility for the safety and efficacy of their products, immediately recall defective medicines and report adverse events within 15 days. The registration exemption is in place until 31 December.
Australia Mulls Relaxation of Laws on Growing Cannabis for Medical Research
The Australian government has proposed changing the law to allow cannabis to be grown for medicinal and scientific purposes. If approved, the legal change would end supply problems created by Australia allowing the use of cannabis in certain contexts, but prohibiting its cultivation.
Export barriers mean it is hard for Australia, or any other country, to rely solely on cannabis grown elsewhere to meet its medicinal and research needs. By establishing a legal framework for the local production of cannabis, the Australian government hopes to end these supply concerns while also facilitating the growth of a new sector in the agricultural industry. The proposed changes to the Narcotics Drugs Act 1967, which are still being finalized, must first win the backing of parliament.
Government officials also intend to work with their peers at the state level to ensure the proposal is acceptable to all groups. Building such a consensus would lessen the risk of the process for the approval and monitoring of cannabis cultivation becoming fragmented across the power structures that make up Australia. “It’s imperative we have a clear national licensing system,” Health Minister Sussan Ley said in a statement.
Ley has already sought to downplay concerns that the relaxation of the law on cultivation will lead to the legalization of recreational cannabis use. The health minister has also emphasized the need for the Therapeutic Goods Administration (TGA) to continue to treat medicinal cannabis in the same way as the other products it regulates. “It’s important we maintain the same high safety standards for medicinal cannabis products that we apply to any other medicine,” she said.Press Release, Reuters
The Pharmaceuticals and Medical Devices Agency, Japan (PMDA) is reportedly planning to set up an office in India. Establishing a presence in India would potentially give Japan a way to increase uptake of generics while maintaining oversight of drug quality. The Economic Times
The Indian Pharmacopoeia Commission (IPC) has published a list of corrections to its monographs. IPC released the list after discovering errors in the seventh edition of the Indian Pharmacopoeia that it published last year. IPC Notice
Tags: CDSCO, DRAP, Pakistan, India, DCGI, marijuana, Australia