Posts

Showing posts from October, 2020

''Nitrosamines''-Is this compound a blow to Pharma Industry..??

Image
 If you go back to 2018, Nitrosamines presence in the drug product were not known to the World. But since then, when  USFDA found the presence of Nitrosamines in the drug Products like Valsartan and Ranitidine, It became talk of the year in Pharma field.                            Nitrosamines are the class of compounds which are usually found in the meet. This compound is considered as cancer causing agent in a research conducted by International Agency for Research on Cancer( IARC). Nitrosamines are probable cancer causing agent to humans.It was first found by USFDA in a valsartan Active Pharmaceutical Ingredient(API) manufacturer from china.              The game started when, All the regulatory authorities like FDA, EMA, WHO,Health Singapore and even Indian CDSCO started to issue orders to the manufacturers to recall their products from the market and submit the product...

What are the Golden rules to stay safe and healthy during Pandemic..??

                                       The Covid-19 Pandemic has shattered the routine life of the world. All the countries are hit by this deadly pandemic.It has taken the life of millions of people across the world.Millions are falling sick. So on this worst time, its very important to maintain the health of us and our family members. I hereby list out few golden methods to stay fit and healthy. 1. Since social distancing has become new normal and mask has been made compulsory, its our utmost duty to follow these rules without fail. This will not only prevent us from getting Covid,but also saves our family and many more. ( Maintain at least 1 meter distance from others). 2. Use hand sanitizers ( preferably alcohol sanitizers) every 30 mins or so, before eating clean the hand and after coming from market, wash the hands atleast for 30 seconds.Dont give shake hands, instead, say nama...

'Quick news on Pharma Industry' Chinese Covid-19 Vaccine show promising results

1.WHO defends data after concluding Gilead's remdesivir flopped Covid-19 trial:- Gilead sciences Inc has questioned the findings that concluded remdesivir does not help patients who have been admitted to hospital, saying the "emerging (WHO) data appears inconsistent". Gilead was given data from the United Nations health agency's trial 10 days ago, to give it an opportunity to react. 2.  Zydus Cadila gets USFDA nod to market Fingolimod capsules, Verapamil Hydrochloride Injection:- Zydus Cadila has received final approval from the United States Food and Drug Administration (USFDA) to market Fingolimod capsules, (Gilenya) in the strengths of 0.5 mg, Zydus Cadila, part of Cadila Healthcare group, said in a regulatory filing. 3.  Chinese Covid-19 vaccine candidate shows promise in human trial: Study:- The latest study, published in The Lancet Infectious Diseases journal, included participants aged between 18 and 80 years and found that antibody responses were induced in a...

Responsibilities of Hospital Pharmacist

  Hospital Pharmacy is any Pharmacy department which is situated inside a hospital premises.The qualified persons who manages the hospital pharmacy with due responsibility are known as hospital Pharmacist.The Pharmacist should be legally qualified,professional. Responsibilities of Hospital Pharmacists are:- 1. Dispensing of drugs and medications as prescribed by the doctor and explaining the patients about dosage regimen. 2. Manufacturing and distribution of the drugs which are prepared in the hospital pharmacies. These include common tablets, creams and capsules. 3. Responsibility of the Pharmacy: The Hospital pharmacist is responsible for purchase of drugs, proper storage of medicines, maintenance of records, Stock check, ordering the medicine which are getting over in the stock etc. 4. Providing therapeutic drug monitoring to the patients, explaining about the doses. 5. Patient interaction and understanding the need for the patients and supplying suitable doses. 6. Patient coun...

What is next after a Pharmacy degree..????

Image
Hello,  What is next is a general doubts that arise in the minds of students who complete a degree..But not anymore....😎            Before jumping to plenty of opportunities in the Pharma field, lets see what exactly is  Pharmacy. Pharmacy Logo                                 Pharmacy  is the clinical health science that links medical science with chemistry and it is charged with the discovery, production, disposal, safe and effective use, and control of medications and drugs. The Pharmacy degree is not just linked to selling of drugs and also not limited to Pharmacy shops. The Pharmacy Degree is rated as one of the most respectful jobs across the world.Pharmacists are considered the life savers. Even the Pharmacy degree is considered one of most difficult courses to pursue with. To begin with scopes and opportunities in the Pharma field,There are diploma in...

Everything to know about COVID 19

Image
  History and Introduction: Corona virus  disease (COVID-19 ) is an infectious disease caused by a newly discovered corona virus. The virus that causes COVID-19 is mainly transmitted through droplets generated when an infected person coughs, sneezes, or exhales. These droplets are too heavy to hang in the air, and quickly fall on floors or surfaces. You can be infected by breathing in the virus if you are within close proximity of someone who has COVID-19, or by touching a contaminated surface and then your eyes, nose or mouth.                                                                                                                                   ...

Association of South East Asian Nations CTD( ACTD)- A overview

Image
Introduction:  The Association of Southeast Asian Nations (more commonly known as ASEAN ) is a political and economic organization aimed primarily at promoting economic growth and regional stability among its members.  Asia’s regulatory systems are diverse, and oftentimes challenging to navigate. The regulatory agency in each Asian country has its own set of regulations and customary manner of conducting business. The following show the various Regulatory Authorities in each countries responsible for registration of medicines:- COUNTRY REGULATORY AGENCY INDONESIA NATIONAL AGENCY OF DRUG AND FOOD CONTROL MALAYSIA DRUG CONTROL AUTHORITY, NCE UNIT PHILIPPINES DEPARTMENT OF HEALTH THAILAND THAI FDA CONTROL DIVISION SINGAPORE HEALTH SCIENCES AUTHORITY BRUNEI MINISTRY OF HEALTH VIETNAM DRUG ADMINISTRATION OF VIETNA...

Tools and Technologies used in eCTD submission

Common Technical Document is defined as a set of specifications which is used for making any application for registration of medicines. This system is used across US,EU and Japan Australia etc. CTD is maintained by  International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. The main purpose of this Document set is to combine all safety, efficacy and quality data which are required for regulatory review process by Authorities ultimately for approval of drug registration.             As we are in 2020, The hard copy of documents are not practical in majority countries. All the submissions to the Regulatory Authority shall be done through various eCTD software's  online. The harmonized CTD specifications are given by ICH guidelines ( Multidisciplinary  guidelines  M4 ).                     The eCTD is defined as an interface for in...