PHARMA LITERATI

A Rajya Sabha Member of Parliament has alleged that four drug companies have bribed doctors across India to push their products, violating the Medical Council of India's code of conduct. USV, Abbott Laboratories, Macleods Pharmaceuticals and Sun Pharmaceuticals allegedly sponsored "pleasure trips" for doctors or, in some cases, doled out cash in violation of the code of conduct, Tapan Sen, a Communist Party of India (M) MP, wrote in a letter to minister of chemicals & fertilizers Anant Kumar. The department of pharmaceuticals said in a report in July that there was a need to take up the issue in the interest of consumers and patients as such promotional expenses extended to doctors had a direct implication on the pricing of drugs and affordability. In addition, the Comptroller & Auditor General, in a report in 2015, criticised the Central Board of Direct Taxes for allowing promotional expenses by pharma companies as deductible expenses while calcula...

The Centre has directed the Indian Institute of Packaging (IIP) to set new packaging standards for pharmaceutical exports to African and Asian countries. " As directed by the government, IIP is developing packaging standards in consultation with leading pharma firms for exports to African and Asian countries. The new packaging standards will be ready by next year ," Joint Secretary in Department of Commerce, Sudhanshu Pandey told reporters after inaugurating the workshop on 'Packaging of Pharmaceutical & Its Safety Aspects ". The decision was taken after a big pharmaceutical order from India got rejected by Vietnam and product was recalled due to packaging issue, Pandey said. " The government will ensure the regulatory body will adhere to the new packaging standards. There can be no compromise on the regulatory standards, quality parameters, " he said. Packaging sector is one of the booming areas of the Indian economy. There is tremendous ...

The Indian Government has been very active in boosting growth and investment in Indian pharmaceutical industry To push India into top five pharmaceutical innovation hubs by 2020 and establish global presence by launching one out of every five to 10 drugs discovered in India at global level, the government is preparing for multi-billion dollar investment with 50 per cent public funding through its public private partnership (PPP) model to enhance innovation capability, reveals the joint study. The Indian Government has been very active in boosting growth and investment in Indian pharmaceutical industry. It allows 100 per cent FDI (Foreign Direct Investment) under automatic route (without prior permission) in the pharmaceuticals sector. FDI favourably impacts the Indian pharma industry by providing access to more capital/funds for investing in Research and Development, which in turn, leads to creation of more IPR, highlighted the study titled 'IPR in pharmaceuticals: Ba...

Indian pharmaceutical companies need to step up their efforts to avoid falling foul of regulations in the United States, according to leaders in the sector. The US is a major export market for Indian pharmaceuticals, for generic medicines, but there have been a series of incidents surrounding the compliance of Indian companies with safety standards set in the US. " The industry has taken this as a challenge and is working closely with the US FDA [United States Food and Drug Administration] and addressing the issues, " said D G Shah, the secretary general of the Indian Pharmaceutical Alliance, speaking at a conference in Mumbai this week. He said that in some cases Indian pharma companies had faced issues because of cultural differences and because they had not kept up to date with changing regulations. Every third pill in the US is manufactured in India and India is the second largest supplier of medicine to the US, after Canada, he said. " For all of u...

The neighbourhood chemist, who doubles as a standby doctor for many Indians, can't be blamed for the raging epidemic of drug-resistant tuberculosis in the country. This endorsement comes from a three-city study published in journal Lancet Infectious Diseases on Thursday. The study found 622 pharmacies in the city, Delhi and Patna doled out antibiotics and steroids with ease to dummy patients who complained of TB-like symptoms. “ Chemists gave medicines to over 80% of simulated patients, who were sent to the pharmacies to enact symptoms of TB such as persistent cough and fever, ” main author of the study Dr Srinath Satyanarayana told TOI. Worse, around 30% of these patients were sold antibiotics. “ Ideally such patients should not have been given antibiotics or steroids and told to go to a doctor. Only 13% of patients were given ideal advice ,” Satyanarayana said. Co-author Dr Madhukar Pai, an epidemiology specialist from McGill University in Canada, said patients were g...

Parents need to be extra careful while giving antibiotics to children as new research has found that the commonly-prescribed drug can significantly increase the risk of Type 1 diabetes . In Type 1 diabetes, the immune system mistakenly destroys the islet cells in the pancreas that produce insulin. Without insulin, patients cannot properly control their levels of blood sugar (glucose), which builds up to damage nerves and blood vessels. A study conducted on mice found that antibiotics changed the mix of gut microbes in their young ones and dramatically raised their risk for Type 1 diabetes. "Our study begins to clarify the mechanisms by which antibiotic-driven changes in gut microbiomes may increase risk for Type 1 diabetes," said Martin Blaser, Professor at New York University (NYU) in the US. In the study, the team examined the effects of exposure to either continuous low-dose antibiotics or pulsed antibiotic therapy (PAT), which mimics the doses used to ...

The Indian Pharmaceutical Association (IPA) has been celebrating the National Pharmacy Week every year during the third week of November. The major focus of NPW celebrations is to create awareness amongst the public, other healthcare providers and the authorities, about the NPW theme in specific and about the pharmacy profession and role of the pharmacist in general. The 55th National Pharmacy Week (NPW) will be celebrated from 20th to 26th November, 2016 . The theme selected for this year is: "Pharmacists for a Healthy India; Role in Prevention and Management of Diabetes" IPA is looking forward to receiving your innovative ideas about how NPW should be celebrated this year as well as about the educational material to be developed to make it most effective and meaningful. Your active participation is most welcome. Please write your suggestions to ipacentre@ipapharma.org ipacpdetimes@gmail.com For more details, please see http://www.ipapharma.org/...

The Central Drugs Standard Control Organisation (CDSCO) may launch online   grant of NOCs for conducting clinical trials soon, under SUGAM, an online solution for submission, application and grant of permission, in compliance with Union health ministry's initiative of e-governance. The application can be submitted and monitored online which will reduce the time of clearance. In this regard, the CDSCO will also be organising a hands-on workshop on 'Online process for Grant of NOC for Clinical Trials' on August 24, 2016 at CDAC Noida and after receiving the feedback, the date of launch will be decided, said an official from CDSCO. He further said the process and document required are the same and it will reduce the time required in submitting the hard copy to the office. The applicant can submit all the required documents and monitor the status of the application. The CDSCO in pursuance of implementation of e governance has launched various services for import...

The manufacturers of pharmaceutical products, medical devices and machineries in the country should have a vision to promote Indian brands of products in the domestic and global markets because despite explosive growth in the pharma sector in the country, people prefer to accept foreign brands, said union minister of state for agriculture, Parashottam Rupala . “People are interested in buying products of all kinds, including medicines, with labels, ‘Made in Taiwan, made in Japan, made in US etc. This has to change and in place, we need the label, ‘Made in India”, the minister said. Rupala made this comment while inaugurating the international pharma technology exhibition, ‘ PharmaTech Expo2016’ , at the Gujarat University Convention Centre in Ahmadabad . “We need to have our own brands of products. Indians opt for foreign brands and this has to be changed. In the field of pharma, separate brand should be made for each category of medicine which should be promoted all ove...

Drug pricing regulator NPPA has revised ceiling prices of 22 formulations of Schedule-I under Drugs (Price Control) Amendment Order, 2016 and Retail Prices of 13 formulations under DPCO, 2013 in related notification dated August 17. Name of the scheduled formulations are ·          atropine injection, ·          ibuprofen tablet -200mg, ·          ibuprofen-400mg, ·          neostigmine injection, ·          carbamazepine oral liquid, ·          diazepam suppository, ·          phenobarbitone injection, ·          nitrofurantoin tablet, ·          rifampicin, ·        ...

Pharmacy Council of India (PCI) has announced the Draft rules & syllabus for the B. Pharm course. The rules and syllabus are framed under Regulation 6, 7 and 8 of the Bachelor of Pharmacy (B.Pharm) course regulations 2014. Please see: http://www.pci.nic.in/CollegesCourses/Revised_Syllabus_Final%20_PCI.pdf PCI has invited for the comments before 6th September 2016. 

Pfizer Inc. and Medivation, Inc. announced that they have entered into a definitive merger agreement under which Pfizer will acquire Medivation, a biopharmaceutical company focused on developing and commercializing small molecules for oncology, for $81.50 a share in cash for a total enterprise value of approximately $14 billion. “ The proposed acquisition of Medivation is expected to immediately accelerate revenue growth and drive overall earnings growth potential for Pfizer ,” said Ian Read, chairman and chief executive officer, Pfizer. “ The addition of Medivation will strengthen Pfizer’s Innovative Health business and accelerate its pathway to a leadership position in oncology, one of our key focus areas, which we believe will drive greater growth and scale of that business over the long-term. This transaction is another example of how we are effectively deploying our capital to generate attractive returns and create shareholder value .” Medivation’s portfolio includes X...

When you last visited your doctor for a stomach infection, did your doctor warn you about the possible side-effects of the prescribed antibiotic, or was there a ` medication guide' in the pack to alert you? Probably not. When 10-year-old Ruchi was prescribed a widely sold antibiotic -ciprofloxacin -for her ENT infection, neither did her doctor inform her parents about the complications, nor was a medication guide available. The pharma company which manufactures the antibiotic too abdicated its responsibility to list possible side-effects. So when Ruchi took the medicine for 15 days, she developed serious skeletal deformities. The antibiotic meant to cure her nearly crippled her. Ruchi is not alone. There are numerous instances of patients suffering serious side-effects after taking prescribed medications, as they were unaware of the drug's possible adverse reaction . So are patients here being given the short shrift? It appears to be the case, as companies in In...