CR TidBit – Indian Pharmacopoeia Commission

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Introduction:

  • Indian Pharmacopoeia Commission (IPC) is an Autonomous Institution. It is controlled by the Ministry of Health and Family Welfare, Government of India.
  • Its basic function is to update regularly the standards of drugs commonly required for treatment of diseases prevailing in this region.
  • It publishes official documents for improving Quality of Medicines by way of adding new and updating existing monographs in the form of Indian Pharmacopoeia (IP).
  • It further promotes rational use of generic medicines by publishing National Formulary of India.

Activities:

  • The Indian Pharmacopoeia Commission came into existence in 2009 with a mandate to periodically publish and update Indian Pharmacopoeia.
  • The Indian Pharmacopoeia Commission has so far published 1977 monographs for different therapeutic categories of drugs and vaccines.
  • The Indian Pharmacopoeia Laboratory became NABL accredited for Biological and Chemicals.
  • The Commission had started analyzing and validating the drug samples received at the Air Port. The Commission had analyzed and validated 206 new drugs.
  • The IP Commission has prepared, certified and distributed 253 IPRS (Indian Pharmacopoeia Reference Substances) paving the way to save invaluable foreign exchange.
  • Guidance manual for Compliance of Indian Pharmacopoeia (IP) was released by IPC on 12th December, 2012.

Pharmacovigilance:

  • The Pharmacovigilance Programme of India (PvPI) was launched on 14-Jul-10. Three hundred medical colleges across the country will be involved in the programme.
  • The basic purpose of the programme is to collect Adverse Drug Reactions (ADRs) to commonly prescribed medicines in India. Approximately 45, 000 ADRs have so far been collected, collated and communicated to WHO – UMC (Uppsala Monitoring Centre), Sweden.
  • Haemovigilance has been launched on 10th December, 2012 under Pharmacovigilance Programme of India.

Reference: http://www.ipc.gov.in & http://www.cdsco.nic.in

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FDA approves first drug treatment for Peyronie’s disease

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The U.S. Food and Drug Administration today approved a new use for Xiaflex (collagenase clostridium histolyticum) as the first FDA-approved medicine to treat men with bothersome curvature of the penis, a condition known as Peyronie’s disease.

Xiaflex is the first FDA-approved non-surgical treatment option for men with this condition, who have a plaque (lump) in the penis that results in a curvature deformity of at least 30 degrees upon erection.

Peyronie’s disease is caused by scar tissue that develops under the skin of the penis. This scar tissue causes an abnormal bend during erection and can cause problems such as bothersome symptoms during intercourse.

“Today’s approval expands the available treatment options for men experiencing Peyronie’s disease, and enables them, in consultation with their doctor, to choose the most appropriate treatment option,” said Audrey Gassman, M.D., deputy director of the Division of Bone, Reproductive and Urologic Products in the FDA’s Center for Drug Evaluation and Research.

Xiaflex is a biologic medicine (made from the protein product of a living organism, collagenase clostridial histolyticum). Xiaflex was first approved by the FDA in 2010 for the treatment of Dupuytren’s contracture, a progressive hand disease that can affect a person’s ability to straighten and properly use their fingers. Xiaflex is believed to work for Peyronie’s disease by breaking down the buildup of collagen (a structural protein in connective tissue) that causes the curvature deformity.

A treatment course for Peyronie’s disease consists of a maximum of four treatment cycles. Each treatment cycle consists of two Xiaflex injection procedures (in which Xiaflex is injected directly into the collagen-containing structure of the penis) and one penile modeling procedure performed by the health care professional.

The safety and effectiveness of Xiaflex for the treatment of Peyronie’s disease were established in two randomized double-blind, placebo-controlled studies in 832 men with Peyronie’s disease with penile curvature deformity of at least 30 degrees. Participants were given up to four treatment cycles of Xiaflex or placebo and were then followed 52 weeks. Xiaflex treatment significantly reduced penile curvature deformity and related bothersome effects compared with placebo.

When prescribed for the treatment of Peyronie’s disease, Xiaflex is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) because of the risks of serious adverse reactions, including penile fracture (rupture of one of the penile bodies within the penile shaft, also known as corporal rupture) and other serious penile injury. Xiaflex for the treatment of Peyronie’s disease should be administered by a health care professional who is experienced in the treatment of male urological diseases. The REMS requires participating health care professionals to be certified within the program by enrolling and completing training in the administration of Xiaflex treatment for Peyronie’s disease. The REMS also requires health care facilities to be certified within the program and ensure that Xiaflex is dispensed only for use by certified health care professionals.

The most common adverse reactions associated with use of Xiaflex for Peyronie’s disease include penile hematoma, penile swelling and penile pain.

Consumers and health care professionals are encouraged to report adverse reactions from the use of Xiaflex to the FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 1-800-FDA-1088.

Xiaflex is marketed by Auxilium Pharmaceuticals, Inc., based in Chesterbrook, Pa.

Source: USFDA Press Announcements

BCG Vaccine Lab in Chennai resumes supply of vaccine for UIP

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The refurbished BCG Vaccine Laboratory in Chennai, which was defunct for the last five years, has now begun re-supply of vaccine for universal immunisation programme (UIP) of the country after resumption of production in February last year.

BCG VL was one of the three closed government vaccine manufacturing companies citing non-compliance of WHO’s GMP standards, in 2008.

According to Dr H G Bramhne, director of the Lab, the unit has supplied 81 lakh doses of vaccine from July to December in 2013, and the last despatch was 60,000 doses to the government of Bihar one month ago. Now a quantity of 36 lakh doses is remaining with the unit and it is under testing.

The resumption of supply was carried out without any publicity or inviting media attention as the vaccine was manufactured in the old lab after rectifying the anomalies found in the inspections. The construction of the new laboratory building is going on in the premises. It will be fully equipped with state of the art machines and will be handed over to BCG VL for operation in next June. Further, a period of six months will be needed for calibration and validation.

On commissioning of the modern Lab, a quantity of 800 lakh doses of vaccine can be manufactured in the facility per year.  Bramhne said he hopes to commence the production in the new building next year. The building is constructed complying the norms of WHO. The production capacity of the existing lab is 400 lakh doses.

“We faced some problems in the old facility while resuming the production after a long period. Several of them were cleared, started the production and resumed supply to different states. The central agency for vaccine procurement gives us the list of places for supply and we despatch the product to those places. We will shortly send the last batches manufactured to central drug testing laboratory in Kasauli for final testing and approval”, the director said.

He said some of the objections raised by the inspectors during various previous inspections have been corrected and the process is going on. After taking over charge as director of the unit, he has changed the documentation and a new master formula was made. Batch Manufacturing Record (BMR), SOPs, and validation documentations were also made for whatever things purchased and validated. The company received assistances from agencies of Standardization Testing and Quality Certification (STQC) and Equipment Test Certification (ETC) for calibration and validation for which better techniques were applied.

According to him, 16 batches of vaccine are made at the existing facility at present. One batch will contain 1.2 lakh doses. The quantity will be increased to the level of 22 very soon. Before closure, BCG VL was supplying 400 lakh doses of vaccine, he said.

To a question, Bramhne said the total requirement of BCG vaccine for UIP in India is 900 lakh doses.

Source: PharmaBiz

 

FDA approves Sovaldi for chronic hepatitis C

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The U.S. Food and Drug Administration today      approved Sovaldi (sofosbuvir) to treat chronic hepatitis C virus (HCV) infection. Sovaldi is the first drug that has demonstrated safety and       efficacy to treat certain types of HCV infection without the need for co-administration of                 interferon.
“Today’s approval represents a significant shift in the treatment paradigm for some patients with chronic hepatitis C,” said Edward Cox, M.D.,            director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and                    Research.
Sovaldi is the second drug approved by the FDA in the past two weeks to treat chronic HCV                 infection. On November 22, the FDA approved Olysio (simeprevir).
Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. Most people infected with HCV have no symptoms of the disease until liver damage becomes apparent, which may take several years. Some people with chronic HCV infection develop scarring and poor liver function (cirrhosis) over many years, which can lead to complications such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in the abdomen, infections or liver cancer. According to the Centers for Disease Control and Prevention, about 3.2 million Americans are infected with HCV.
Sovaldi is a nucleotide analog inhibitor that blocks a specific protein needed by the hepatitis C virus to replicate. Sovaldi is to be used as a component of a combination antiviral treatment regimen for chronic HCV infection. There are several different types of HCV infection. Depending on the type of HCV infection a patient has, the treatment regimen could include Sovaldi and ribavirin or Sovaldi, ribavirin and peginterferon-alfa. Ribavirin and peginterferon-alfa are two drugs also used to treat HCV infection.
Sovaldi’s effectiveness was evaluated in six clinical trials consisting of 1,947 participants who had not previously received treatment for their disease (treatment-naive) or had not responded to previous treatment (treatment-experienced), including participants co-infected with HCV and HIV. The trials were designed to measure whether the hepatitis C virus was no longer detected in the blood at least 12 weeks after finishing treatment (sustained virologic response), suggesting a participant’s HCV infection has been cured.
Results from all clinical trials showed a treatment regimen containing Sovaldi was effective in treating multiple types of the hepatitis C virus. Additionally, Sovaldi demonstrated efficacy in participants who could not tolerate or take an interferon-based treatment regimen and in participants with liver cancer awaiting liver transplantation, addressing unmet medical needs in these populations.
The most common side effects reported in clinical study participants treated with Sovaldi and ribavirin were fatigue and headache. In participants treated with Sovaldi, ribavirin and peginterferon-alfa, the most common side effects reported were fatigue, headache, nausea, insomnia and anemia.
Sovaldi is the third drug with breakthrough therapy designation to receive FDA approval. The FDA can designate a drug as a breakthrough therapy at the request of the sponsor if preliminary clinical evidence indicates the drug may demonstrate a substantial improvement over available therapies for patients with serious or life-threatening diseases. Sovaldi was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that treat serious conditions and, if approved, would provide significant improvement in safety or effectiveness.
Sovaldi is marketed by Gilead, based in Foster City, Calif. Olysio is marketed by Raritan, N.J.-based Janssen Pharmaceuticals.