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    Asia Regulatory Roundup: India Considers Phasing Out Gelatin-Based Capsules (12 April 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. DCGI Seeks Feedback on Proposal to Phase Out Gelatin-Based Capsules The Drug Controller General of India (DCGI) is seeking feedback on a proposal to replace gelatin with cellulose in drug capsules. If enforced, the transition would represent a major change for the capsule manufacturing industry, the output of which is currently dominated by gelatin-based products. DCGI i...
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    Asia Regulatory Roundup: India Reverses Opposition to Off-Label Ophthalmic Use of Avastin (15 March 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Reverses Opposition to Off-Label Ophthalmic Use of Avastin India has quickly reversed its opposition to the off-label ophthalmic use of Roche’s Avastin (bevacizumab).  Drug Controller General of India Dr. GN Singh warned against using Avastin in ophthalmology conditions in January after reports linking it to loss of vision emerged, only to withdraw the alert th...
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    Asia Regulatory Roundup: CFDA Begins Overseas Inspections (26 January 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Warns Indian, Japanese Manufacturers as Overseas Inspection Drive Begins China Food and Drug Administration (CFDA) has found fault with the manufacturing practices of four foreign drugmakers, the highest profile of which is India’s Aurobindo Pharma. The regulator framed the warnings as part of an initiative to step up its oversight of companies that are importing ...
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    Asia Regulatory Roundup: Dengue Vaccine Nears Approval in India Without Local Phase III Data (19 January 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Sanofi Secures Indian Committee Approval for Dengue Vaccine Without Local Phase III Data An Indian drug regulatory committee has recommended allowing Sanofi to bring its Dengue vaccine to market without first generating Phase III data in a local trial. The committee thinks the divergence from normal protocol is acceptable given the scale of the health threat posed by the D...
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    Asia Regulatory Roundup: India Looks to Raise Drug Inspection Standards (20 October 2015)

    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 ...
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    Asia Regulatory Roundup: India Looks to Join Pharma Inspection Scheme (15 September 2015)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Abbott Contests Indian Allegations of Substandard Cough Syrups A dispute between Abbott and regulators in India has raised doubts about the effectiveness of the quality testing regimens implemented by local authorities. The case centers on a sample of a product branded as Abbott’s cough syrup Phensedyl that was found to contain twice as much codeine as was listed on t...
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    India’s CDSCO Sets up Whistleblower Reward Scheme

    India’s Central Drugs Standard Control Organisation  (CDSCO) has set up a scheme for providing monetary rewards to informers who provide specific information leading to the seizures of spurious, adulterated, misbranded and not-of-standard-quality drugs, cosmetics and medical devices. This reward scheme will be applicable to both the informers and CDSCO officers involved. The plan calls for rewards of up to 20% of the value of the products seized, to a maximum of a...
  • CDSCO Clarifies the Role of its International Unit

    India's Central Drugs Standard Control Organization (CDSCO) has posted the organizational structure and functions of its recently-formed International Cell , which interfaces with foreign governments and regulatory agencies and investigates reports of quality concerns with India drug exports.  Among its other functions, the Cell focuses on bilateral Memoranda of Understanding (MOUs), grants written confirmations for active pharmaceutical ingredient (API) exports f...
  • India to Require Notification of Foreign Drug Import Alerts

    Indian pharmaceutical companies will now be required to inform the Central Drugs Standard Control Organization (CDSCO) about any drug import alert restrictions imposed on their products by foreign regulatory authorities, according to a new notice issued on 26 June 2013 by the Drugs Controlled General of India (DCGI). The notice highlights the fact that local manufacturers whose drugs are the subject of foreign regulatory action also supply the same or similar drugs on ...
  • In Wake of Broader Concerns, India's DCGI Creates Panel to Investigate Drug and Trials Approvals

    India's Drugs Controller General (DGC), in an order dated 26 March 2013 , has convened a special committee to investigate allegations that the Central Drugs Standard Control Organization (CDSCO) did not adhere to "scientific requirements and … regulatory compliance" in four cases involving the approval of drugs and clinical trials.  The order was issued at the request of the Parliamentary Standing Committee with oversight authority for the CDSCO.  Th...
  • Two New Indian Advisory Committees to Generate New Guidelines for Clinical Trials, Drugs

    The Drugs Controller General of India (DCGI) for the Central Drugs Standard Control Organization (CDSCO) has requested input from the public regarding two newly formed independent advisory committees. The first committee, the Expert Committee to formulate policy guidelines and SOPs for approval of new drugs, clinical trials and banning of drugs, will be chaired by Prof. Ranjit Roy Chaudhury and include six other members. The committee's charge will be to fo...
  • CDSCO Says Local Authorities Improperly Approving New Drug Products

    India's primary drug regulatory body, the Central Drugs Standard Control Organization (CDSCO) is reaching out to all regional and state drug regulatory bodies under its supervision, reminding them that they cannot approve new drugs or new fixed dose combinations (FDCs) and giving sponsors of unapproved, marketed drugs 18 months to obtain approval from CDSCO. In a letter dated 15 January 2013, Drugs Controller General of India G.N. Singh reiterated that by law, CDSCO mu...