Posted 05 July 2017
By Nick Paul Taylor
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
DCGI Asks Industry How to Further Cut Regulatory Burdens
DCGI Dr. GN Singh has asked the industry how his agency can further reduce the regulatory burden companies face. Singh put out the call for suggestions about how DCGI can streamline drug regulation as part of a release detailing the changes it has already made to make it easier to do business in India.
The industry has until 31 July to make suggestions and a blank slate with regard to the scope of its ideas. Singh’s only stipulation is that the issues respondents want DCGI to address must fall under the jurisdiction of the drug regulatory regime.
While Singh’s willingness to countenance all ideas suggests respondents can make a wide range of suggestions, the other part of his missive indicates DCGI has already tried to address many topics. Singh’s letter begins with a list of around 40 documents Indian regulators have published since July 2014 to streamline oversight of the drug industry. The years highlighted by Singh cover the period since Narendra Modi was elected as prime minister after running on a platform that prioritized making India a better place to do business.
Singh described the actions taken to date as being in “compliance to the directions of the government to reduce the layers/steps for providing prompt services to the stakeholders.” Having implemented the measures, Singh thinks DCGI has accelerated “regulatory approvals/clearances without compromising the safety, quality and performance of medical products.”
Some of the legislative changes highlighted by Singh are broad in their scope. For example, the list includes the October 2015 notice that established definitions for clinical trial, global clinical trial, investigational new drug and new chemical entity. Other changes are more specific. For example, Singh also included a document related to homeopathic hair oils on the list of legislative texts.
DTAB Calls for Higher Pay, Minimum Qualifications for State Regulators to Raise Standards
India’s Drugs Technical Advisory Board (DTAB) has recommended raising the pay and minimum qualifications of state drug regulators. The DTAB proposal is intended to improve standards by reducing state-to-state variation in the implementation of the Indian Drug and Cosmetics Act.
DTAB is advocating for the restructuring of state drug control organizations. Specifically, DTAB wants to rebrand “drugs inspectors” as “drugs control officers” and raise their pay. People currently employed as drugs inspectors will see their grade pay increase from Rs 4,800 to Rs 5,400 ($74 to $83) a month. Grade pay is one of several components of the pay of Indian government employees and is tied to the band in which the worker is grouped. Other pieces of the pay packet typically provide more money than the grade pay.
The increasing of the grade pay for drugs inspectors will have effects further down the employment ladder. DTAB is proposing to increase the grade pay of assistant drugs inspectors to Rs 4,800. All other senior positions “should accordingly be re-organized,” DTAB said.
In the past, drugs inspectors have demanded pay increases from the government, but DTAB’s proposal is not directly tied to these complaints. Rather, the board wants to make pay increases part of a broader initiative to raise standards at state drug regulators.
Other aspects of the proposals will ask more of state officials. Notably, DTAB wants to raise the minimum experience state licensing authorities must possess to oversee the manufacturing and sale of drugs. DTAB shied away from specifying what experience licensing authorities should have, saying only that it wants to see the bar “raised adequately.”
The board was more prescriptive in its proposal for the restructuring of state licensing authorities. DTAB is proposing to end the practice of having multiple licensing authorities in a state. Instead, the board is recommending each state has a single licensing authority that delegates powers to other regulatory officials.
DTAB expects the central government to contribute to the harmonization of the implementation of drug laws. The board is calling for the central government to provide direction to states about how many regulatory officials they need to oversee their jurisdictions. DTAB wants to see states employ one official for every 200 sales outlets and another one for every 50 manufacturing units. The recommendations also call for the deputation of state officials to the central regulatory group and vice versa.
DTAB lifted those recommendations word for word from a list made previously by its counterpart, the Drugs Consultative Committee (DCC). The main changes to the DCC list were the additions of two recommendations. DTAB’s additions proposed qualifications and experience levels for medical device officers and advocated for state regulators to be rebranded as regional outposts of the Indian Drug Administration (IDA).
Earlier this year, DTAB called for the Central Drugs Standard Control Organization (CDSCO) to be rebranded as IDA. The latest recommendation would build on this change by creating the Andhra Pradesh IDA, Gujarat IDA and an IDA for each other state in India.
Some recommendations made by DTAB and DCC are never implemented, but the board holds an influential position. The main functions of DTAB and DCC are to advise the Drug Controller General of India (DCGI).
DTAB Minutes, DCC Minutes
TGA Shares Guidance on Making Substantial Changes Affecting Device Conformity Assessments
The Therapeutic Goods Administration (TGA) of Australia has released a guide for companies with conformity assessment certifications that are planning to make changes to their operations. TGA has designed the guide to help companies understand when they must notify it of their plans.
Notifications are required for “substantial” changes to quality management systems, the range of products covered by these systems and the design of medical devices. TGA lists examples of what it classes as “substantial” changes for each grouping.
For TGA certificates associated with quality management systems, the agency lists changes to the name or address of the manufacturer, details of its facilities and information relating to critical suppliers as examples of substantial changes. Changes to quality management system processes are also affected by the notification requirements. If, for example, a company changes its sterilization method, a drug coating process or a viral inactivation process, it must notify TGA.
Many changes to device design also necessitate a notification. TGA picked out the broadening of the clinical indications targeted by the device, changes to the product’s materials and alterations that may affect its sterile barrier integrity as actions that it wants to hear about.
TGA has also provided a shorter list of changes that do not require a notification.
The agency released the guideline alongside details of its repository of conformity assessment certificates. TGA is creating the system to automatically generate conformity assessment certificates once the application process is complete. This may change how the certificates look. More significantly, TGA will use information in the repository to pre-populate an online conformity assessment application form it plans to introduce.
TGA Guidance, Assessment Section
The director of administration at DCGI has written to joint, deputy and assistant drug controllers to urge compliance with grievance handling procedures adopted earlier this year. The notice states applicant grievances with the decisions of subject expert committees are not being handled as DCGI dictated. DCGI is viewing the failure to follow the process “very seriously.” Letter