Drug Information Bulletin (Electronic)

Volume: 4

Drug Information Centre (DIC) Indian Pharmaceutical Association, Bengal Branch Tele fax: 033 24612776, E-mail: ipabengal.dic@gmail.com Web Site: http://www.ipabengal.org Contact: 09830136291

Number: 36

18 December 2010

Content DCGI to introduce Preliminary Scrutiny for approval of FDCs from January 2011 Pfizer Pulls PAH Drug Due to Liver Toxicity Reckitt Benckiser Group buys Indias Paras Pharmaceuticals Ltd Healthcare Industry Now Offering Improved Diagnoses, Earlier Interventions, and Better Medical Outcomes with Personalized Medicine Supreme Court directs Universal Access to Second Line ART in a phased manner Forthcoming Events

DCGI to introduce Preliminary Scrutiny for approval of FDCs from January 2011 Aiming to streamline the submission of application for approval of Fixed Dose Combination (FDC) drugs and their review by the drug authorities, the Drug Controller General of India (DCGI) has introduced a system of 'preliminary scrutiny' of such applications while receiving them to determine the acceptability for review by the DCGI office. This will come into effect from January 1, 2011. The new system is intended to avoid unnecessary delays in approvals of FDC applications. So far, the applicants have used many different approaches in organizing the information and the differences in organization of data in each application has made reviewing more difficult and can also lead to omission of critical data or analyses which could result in unnecessary delays in approvals.

The preliminary scrutiny of the applications will be done by CDSCO officers based on checklists prepared for each of the several categories of FDC. During the preliminary examination, the CDSCO officers will scrutinize the applications to ensure that it contains all the required administrative as well as technical information in proper manner as per the checklist. If application submitted is not in accordance with the format and the checklist, it will not be accepted by CDSCO. Once an application is accepted, the adequacy of the data will be reviewed by CDSCO as per the specified requirements and guidelines. In case the data submitted is not adequate or satisfactory, applicant will be requested to generate/submit adequate data for consideration and approval of the FDC. The proposed fixed dose combination should be based on therapeutic rationale. The applicant is required to justify the combination based on the rationale. While

submitting the rationale for a FDC, the applicant must address the issues like drugdrug interaction between the ingredients, food effects and dosage schedule of individual active ingredients vis-a-vis that of the FDC. Further, the indication/claim for the FDC should be such that the individual active ingredients makes a contribution to the claimed effect and the product should be formulated so that the dose and proportion of each substance in the FDC is appropriate. Trial batches of new drugs for test and analysis/clinical trial/BE study purpose should be manufactured after obtaining Licence in Form 29 from the concerned State Licensing Authority and copy of the licence should be submitted along with the application. While submitting reply to a query, the applicant should always enclose with the reply, a copy of query letter issued by CDSCO. The applicant should submit stability data generated on 3 trial batches manufactured by them under Licence in Form 29 issued by State Licensing Authority (SLA). The stability data and the clinical trial protocol should be submitted as per the CDSCO format. In case of clinical trial/ bioequivalence study NOC, the applicant should submit the adequate chemical and pharmaceutical information. The applicant should always submit certificate of analysis, dissolution data (in case of oral dosages form, as appropriate), stability study data etc. in respect of formulation, duly signed by the Incharge/Manager QC. Before preparing the application, the applicant must categorise their proposal and submit information as per the checklist for that category. Application in Form 44 should be complete in all respects and signed by the authorized person of the firm with name and designation. The TR challan receipt submitted by the applicant should mention the name of the FDC including correct head of the account, payable at, bank clearance,

2 etc. The documents must be submitted with indexing and page number. Without indexing or page number, no application will be accepted. Clear and unequivocal information should be provided along with the application.
Source: Pharmabiz

Pfizer Pulls PAH Drug Due to Liver Toxicity Pfizer is to voluntarily withdraw sitaxentan (Thelin), a drug for pulmonary arterial hypertension (PAH), following two cases of fatal liver toxicity [1]. The drug has been marketed in 16 countries in the European Union and in Australia and Canada; clinical trials with the compound will also be discontinued, and the company no longer plans to file a US new drug application. Pfizer says its decision is based on "a review of emerging safety information from clinical trials and postmarketing reports." While liver toxicity is a known complication of the class of drugs to which sitaxentan belongs, the company says a new potentially lifethreatening idiosyncratic risk of liver injury has been observed. "Given the availability of alternative treatments, Pfizer has concluded that the overall benefit of Thelin no longer outweighs the risks in the general population of PAH patients," the company says in a statement. Alternative treatments for PAH include the dual endothelin antagonist bosentan (Tracleer, Actelion Pharmaceuticals), the endothelin A receptor antagonist ambrisentan (Letairis, Gilead Sciences), and two phosphodiesterase type-5 inhibitors better known for their treatment of erectile dysfunction but repackaged with new brand names for PAH, sildenafil (Revatio; Pfizer) and tadalafil (Adcirca, United Therapeutics).
Source: Medscape Pharmacist

3 Reckitt Benckiser Group buys Indias Paras Pharmaceuticals Ltd Reckitt Benckiser Group plc (RB) announces that it has agreed to buy Paras Pharmaceuticals Limited (Paras) for INR 32.6 billion (Indian Rupees) (approximately GBP 460 million) from the current shareholders, including the Patel family and Actis, the emerging markets private equity investor. RB will finance the transaction from existing facilities. Paras is a privately-owned Indian company with a portfolio of leading Indian over the counter Health and Personal Care brands including:

Moov, the No 2 topical analgesic pain ointment, DCold, the No 2 cold & flu remedy, Dermicool, the No 2 for prickly heat, Krack, the No 1 medicated skin treatment for cracked heels and Itch Guard and Ring Guard anti fungal creams.

markets in the world with the addition of a number of strong and leading brands. We believe the Paras business has not only extremely good growth potential, when supported by RBs investment and innovation strength, we also expect to realize material synergies as a result of the integration of Paras into Reckitt Benckiser. The growth potential of the business, the creation of a material health care business in Indias large and growing health care market and the global synergies available make Paras an exciting addition to our portfolio and attractive opportunity for our shareholders. RB was advised by J P Morgan. Actis and the other Paras shareholders were advised by Morgan Stanley.
Source: www.rb.com

Healthcare Industry Now Offering Improved Diagnoses, Earlier Interventions, and Better Medical Outcomes with Personalized Medicine The success of personalized medicine depends on accurate diagnostic tests. Experts believe that personalized medicine will eventually become the standard of care, but advancements in science and diagnostic technology, regulatory frameworks, and insurance reimbursement are required. Once the groundwork is laid, the benefits will be many, including reduced costs of healthcare by eliminating ineffective treatments, faster approvals due to predictable safety and efficacy, lower rates of adverse reactions, earlier detection, and prevention. Within the next few years, genomic information will prevent disease and more effectively treat and diagnose disease. PharmaLive's Personalized Medicine and Orphan Drugs Review & Outlook report examines the personalized medicine and orphan drug sectors, companies involved, as well as the drugs, technologies, and business strategies that are driving growth. DX Directions' IVDs for Personalized Medicine

In addition, Paras has a personal care business led by Set Wet, a leading hair gel and deodorant brand. In the fiscal year ending March 2010, Paras generated net sales of INR 4,014 million, representing a mid-teens average growth rate over the last four years, and operating EBITDA for the same year of INR 1,083 million (approximately GBP 56 million and GBP 15 million respectively). The company has a brand new state of the art and GMP compliant manufacturing plant located at Baddi in Northern India, which employs around 700 people. Commenting on the acquisition, Reckitt Benckiser CEO, Bart Becht, says, The acquisition of Paras is another step forward in RBs growth strategy in consumer health care. It creates a material health care business in India, one of the most promising health care

4 report provides a comprehensive review of technology issues in developing companion IVDs, demonstrating clinical utility in personalized healthcare, reimbursement and regulatory issues, as well as consumer engagement in personalized medicine.
Source: Pharmalive.com

Supreme Court directs Universal Access to Second Line ART in a phased manner Sankalp Rehabilitation Trust had filed an application in the above petition in the Supreme Court challenging the constitutionality of NACO's criteria for second line ART and seeking a direction that second line be made available to all those who need it, irrespective of any other criteria. Under Indian law, commenting on the merits of a case which is pending before a court amounts to contempt. The update below is a fair reporting of the proceedings before the Supreme Court in this matter. The Petitioner argued that limiting access to 2nd line was violative of fundamental right to life of PLHIV. Taking a serious view of the situation, the Hon'ble Supreme Court made it clear to the government that access to second line must be universalized. On 16th December, the following statement, appended below, was endorsed as an order of the Hon'ble Supreme Court. As per the order, second line ART will be provided to all PLHIV who need it, whether they were in the private or public sector or on rational or irrational treatment. In the first phase (3 months), universal access to second line treatment would be started at four Centres of Excellence (JJ Hospital in Mumbai, GHTM Tambaram,

Maulana Azad Medical College (MAMC), New Delhi and Calcutta School of Tropical Medicines, Kolkata) with immediate effect. This pilot initiative would be studied over a period of three months, after which it will be scaled up to more ART Centres. Lawyers Collective HIV/AIDS Unit will organize a meeting in January 2011 with PLHIV and NACO to further explain the order and discuss the remaining issues in the ART Rollout Programme. Forthcoming Events: National Seminar on: Chemical & Pharmaceutical Industries in India - Present Scenario & Future Prospects to commemorate the 150th Birth Anniversary of Acharya Prafulla Chandra Roy, to be held on 21st & 22nd January, 2011 Jointly organized by: Indian Institute of Chemical Engineers (Calcutta Regional Centre) & Alumni Association, Jadavpur University National Conference on: Emerging Research Trends in Natural Product

February 12-13, 2011 Pre conference workshop on Quality Evaluation of Natural Products February 11, 2011 Organized by: School of Natural Product Studies Jadavpur University, Kolkata

Website: www.jaduniv.edu.in; www.aptiindia.org