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Regulatory News | 28 May 2015 | By Nick Paul Taylor
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
Indian pharma companies are offering regulatory affairs officials premium pay packets to attract and retain talent. The well-known regulatory problems faced by Indian manufacturers have led to many businesses bolstering their regulatory teams, which in turn has created a skills shortage.
Recruitment consultancy TeamLease made the observations in its annual jobs and salaries primer, PharmaBiz reports. TeamLease found regulatory affairs professionals sit alongside occupational therapists and data analytics-focused product marketers as the experts most in demand at Indian pharma companies. The scramble to hire top talent in the wake of repeated punishments from foreign regulators has exposed a skills shortage within the local industry.
“There is definitely a shortage of specialists because these are not glamorous postings and with not too much access to talent,” said Rituparna Chakraborty, senior vice president and co-founder, TeamLease. The shortage is a positive for regulatory affairs professionals in India, who have seen their salaries rise. Average salaries across the industry are increasing by more than 10% a year, suggesting regulatory affairs professionals have experienced a significant jump in remuneration.
Australia’s Therapeutic Goods Administration (TGA) has warned it is failing to meet its timelines for processing good manufacturing practice (GMP) clearance applications. The regulator said the problem stems from a 60% jump in the number of applications over the past four to five years.
In 2010, TGA received 2,500 GMP clearance applications. Now, the annual rate has risen to 4,000, a number TGA is unable to handle with its current infrastructure. The regulator published a note this week to explain it is failing to meet its target timelines consistently, a shortcoming that has prompted officials to rethink how they approach the task. TGA is implementing a series of reforms to improve the situation.
The plan is to collect performance data and scour them for evidence of inefficiencies in the way TGA processes applications. Once TGA has a better idea of where it is going wrong, officials will talk to the industry about how it intends to overcome the problems. The TGA Industry Working Group on GMP plans to issue updates over the coming months. Until then, TGA is asking industry applicants to ensure they include all the required information in their filings.
India's National Pharmaceutical Pricing Authority (NPPA) has contacted manufacturers of orthopedic implants to request pricing data, including what a product costs at each step in the supply chain and how much the fee has increased in recent years. The letter follows media reports criticizing the pricing of such medical devices.
Various laws cover the pricing of medical products such as orthopedic implants in India and limit the amounts for which they are sold. NPPA reminds manufacturers in its letter that hikes in the maximum retail price (MRP) of 10% or more a year are prohibited, as is the sale of a device for more than the amount detailed on the current price list. Media reports suggest some players in the orthopedic implant supply chain are failing to comply with these laws.
To support an investigation into the matter, NPPA has asked manufacturers to provide data on the factory price, distributor cost and MRP of their orthopedic implants. NPPA also wants to know by how much the MRP has increased over the past three years. The pricing organization has given the industry just seven days to provide the information, after which it will start an investigation informed by the data it receives.
The Drug Regulatory Authority of Pakistan (DRAP) has reworked regulations on stability data. DRAP now wants manufacturers to file for registration on the basis of laboratory-scale feasibility studies and then submit stability data from three commercial-scale production runs.
Dr Mohammad Aslam, the recently-appointed CEO of DRAP, implemented the new process as part of wide-reaching attempts to ensure the quality, safety and efficacy of drugs sold in Pakistan. Aslam identified stability data as an area in which Pakistan falls short of International Conference on Harmonization (ICH) standards, leading him to propose — and win backing for — a reworking of the regulations at a meeting of the registration board.
The new way of working is expected to stop illegal practices. “Drug manufacturers would adopt illegal ways to import molecules because they had to submit stability reports without registration. Now, they will have to first register the medicine and will submit their stability report,” Aslam told Dawn. In a separate development, the National Accountability Bureau (NAB) has created a committee to stamp out corruption in Pakistan’s health sector.
India’s National Pharmaceutical Pricing Authority (NPPA) has published a list of companies that are yet to register for its online database. The number of registrants has increased over the past month, but Ranbaxy, Zydus Cadila and 30 other leading drugmakers are yet to sign up.
NPPA has written to the 32 companies to tell them to register immediately. Since NPPA last wrote to the businesses in the first week of May, 27 companies — including notable drugmakers such as Biocon and Dr Reddy’s Laboratories — have signed up, but one-third of the top 100 manufacturers are still yet to register. The list of outstanding companies includes Merck’s consumer healthcare business, Ranbaxy and Zydus Cadila.
The original deadline for registration was the end of October, but 30 of the companies contacted by NPPA are yet to contact the team coordinating the program at the National Informatics Centre. NPPA needs a complete and accurate database if the project is to achieve its goals. Officials set up the initiative to move filings for the monitoring, fixing and revising of prices online, a shift NPPA sees as helping it to fulfill its duties.
The Maharashtra Food and Drug Administration (FDA) is continuing its campaign to bring cardiac stents under price control. Officials at the state regulator have written to NPPA to request the price fixing body extend its remit to cover cardiac stents. Maharashtra FDA began lobbying for changes after investigating the markup of prices on cardiac stents. The Economic Times
The CEO of a stem cell company has criticized the ambiguity of regulations covering the sector in India. Advancells CEO Vipul Jain said the lack of clear regulations is driving stem cell graduates to seek employment in other, more secure fields. Indian regulators are currently creating a group to draft new guidelines, but Jain thinks it will take up to two years to establish a system. PharmaBiz
NPPA has written to manufacturers of intravenous fluids to ask for pricing data. The price control body is still waiting for manufacturers to submit price-to-retailer (PTR) and moving annual total (MAT) data from September 2013, information it has now asked for three times this year. Failure to supply the data could lead to non-compliance. DNA
The Indian Pharmacopoeia Commission has asked the industry to submit adverse event reports in xml-E2B format. Standardizing submissions on the format is intended to cut the time it takes to upload files to the World Health Organization’s database, while also making it easier to assess and identify trends worthy of investigation. IPC Letter
Tags: Asia Regulatory Roundup, Regulatory Roundup