Tuesday, 30 August 2016

Pharma cos offer freebies to doctors, violate code: MP

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 calculating tax. "I am waiting for the minister's response on this issue. Nothing has come so far. We also have the names of the doctors who have taken bribes, which we will release eventually," Sen told ET. Three of the companies denied any wrongdoing and one could not be reached for comment.

Sen lists allegations such as Sun Pharma paying for tickets for a pleasure trip to Srinagar for nine doctors and its Stancare division picking up the hotel bill for a doctor; money paid by USV to 13 doctors for a trip to Vancouver and an amount of `16,38,200 directly paid to 149 doctors in Madhya Pradesh; Abbott IndiaB paying money to 300 doctors and Macleods Pharma paying money to about 40 doctors in Karnataka and Uttar Pradesh.

The names are based on an investigation by People's Health Movement, an NGO that presented its report to the ministry last year. All these acts are a gross violation of the code of conduct formulated by the Medical Council of India, Sen wrote. "So far, MCI had not taken any action when complaints were filed to them. But this code is only applicable to doctors," he said in the letter.

US drug maker Abbott said its interaction with doctors is guided by the company's code of conduct and policies, laws and industry codes. "Our policies don't allow any activity with doctors as an incentive to recommend or prescribe Abbott products. We also have strict policies against providing entertainment, gifts, leisure activities or incurring expense for a doctor's family," an Abbott spokesperson said in response to an email query from ET. Sun Pharma said it is not aware of any letter written by any MP.

"Sun Pharma takes compliance very seriously and ensures that all our business practises remain compliant with all requirements," it said.

Govt to set new packaging standards for pharma exports

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 growth in Indian pharmaceutical manufacturing, which also cater to the requirements of the global pharmaceutical industry, IIP Director N C Saha said. IIP is a national apex body under the Ministry of Commerce and Industry, with the specific objective of improving the packaging standards in India.

The country's pharmaceutical sector is the third largest in terms of volume and thirteenth largest in terms of value. India is the largest provider of generic drugs globally with the Indian generics accounting for 20 per cent of the global exports in terms of volume. Domestic pharma industry is expected to grow over 15 percent per annum to outperform the global pharma industry, which is set to grow at an annual rate of 5 percent, Saha said. The market is expected to grow to USD 55 billion by 2020, thereby emerging as the sixth largest pharmaceutical market globally by size, Saha added.

Indian packaging industry is capable of meeting the global expectations. This has been a major factor in the success story of Indian pharmaceutical manufacturers and exporters, despite of having high demanding standards of the importing countries especially by the developed countries. In today's consumer - driven market, even pharmaceutical packaging can influence a customer's choice, based on its appearance and attributes, he said. In competitive market, with the continually rising pharmaceutical and healthcare segment in the country, there will be an enormous demand for packaging materials with effective functional properties and systems to augment the shelf life, retain efficacy and ascertain the brand representation for various products. This will go a long way in fulfilling the consumer's expectation of safety, particularly with the additional features of tamper evident and anti-counterfeit.

India to be amongst top five global pharma innovation hubs by 2020: Assocham

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: Balancing, innovation and access,' jointly conducted by ASSOCHAM and TechSci Research.

The Government has been actively undertaking policy initiatives for growth of the pharmaceutical industry. One such initiative is tax-breaks in the pharmaceutical sector.

There is also a weighted tax deduction at a rate of 150 per cent for the research and development expenditure incurred.

Steps to streamline methods for development of a new drug molecule, or clinical research, etc., have also been considered. Indian Government also launched two schemes including New Millennium Indian Technology Leadership Initiative in 2003, and the Drugs and Pharmaceuticals Research Programme in 1994-95, specially targeted at pharmaceutical research, adds the study.

The Department of Industrial Policy and Promotion (DIPP) data suggests that the drugs and pharmaceuticals sector in India has attracted FDI worth $1,523 million during April 2014-March 2015.

Additionally, industrial licenses are not essential in India for most of the pharmaceutical products. Hence, drug manufacturers are free to develop any drug upon approval by the Drug Control Authority.

The act of protecting one's innovation through a patent has initiated investments from many multinational pharmaceutical companies in India. These MNCs are looking at India for its strength in contract manufacturing and as an attractive base for research and development (Research and Development), particularly for conducting clinical trials and other services.

Indian and foreign pharmaceutical companies are progressing with rising patented drug launches in India. The Indian Patent Office granted 2008 patents between 2010 and 2013.

The Department of Pharmaceuticals has drafted Pharma Vision 2020 document, with an aim to establish India as a leading county for end-to-end drug manufacturing and innovation. This initiative by the government aims at providing support to Indian pharmaceutical sector through state of- the-art infrastructure, internationally competitive scientific research personnel for pharmaceutical Research and Development, and funding for research in the public and private sectors.

The Central Drug Standard Control Organisation (CDSCO), which falls under the scope of the Ministry of Health and Family Welfare, is the main pharma regulatory body in India. The Drug Controller General of India (DCGI) presides over the CDSCO at both the central and state levels.

Sun Pharmaceuticals acquired Ranbaxy Laboratories in 2015, in order to achieve full compliance with regulatory framework for drug manufacturing in India, meet expectations of Indian regulatory authorities, and increase Research and Development for launch of innovative products, thereby generating high revenues across India.

Saturday, 27 August 2016

Indian pharma steps up efforts on US safety standards

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 us in India, the US is very important," said Habil Khorakiwala, the founder chairman of Wockhardt, one of India’s biggest pharma firms. "Irrespective of what are the FDA requirements, we need to create organisation which meets whatever is the requirement of the FDA. I can tell you from our own experience that the standard they expect outside the US is much higher than in the US.

      "I think in two, three, four years, you will find state of the art manufacturing facilities in India, so I think it is a blessing in disguise, whatever has happened."
      Mr Shah said that 102 warning letters were issued by the US FDA between August 2013 and August 2016, with 51 letters being issued within the US and 26 letters being sent to Indian companies.
      "Considering the volume of medicine that we supply to the US, it’s just natural that some of the warning letters come to Indian companies," said Mr Shah.

        The Indian drugs firm Ranbaxy Laboratories three years ago had to pay a record fine of US$500 million for lying about its methods of testing medicine and for manufacturing substandard drugs in a settlement agreement with the US department of justice.
        The FDA in 2013 placed bans on two factories in India operated by Wockhardt, because of concerns over production quality. These were the drugmaker’s main plants for exports to the US.
        Source:  http://www.thenational.ae/business/economy/indian-pharma-steps-up-efforts-on-us-safety-standards

        Friday, 26 August 2016

        Chemists not to blame for drug-resistant TB, says study

        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 given antibiotics despite regulations against dispensing them without prescriptions and this could be fuelling anti-microbial resistance.

        The study was undertaken to understand the role of pharmacies in fuelling drug-resistance in community. Two sets of dummy patients were trained and sent to 622 pharmacies in Mumbai, Delhi and Patna. While the first set were trained to enact TB symptoms and ask for medicines, the second set was given a diagnostic report to show they had TB. “In the second set of patients, we found the chemists were extremely careful. For 62% of these patients, they were very cautious once the diagnosis was there,” said Dr Satyanarayana. The authors said their pharmacies' study provided the backdrop for another study published in Lancet Infectious Diseases on Thursday, which showed India's drug-sensitive TB burden was twice of what has been estimated so far.

        The other study ­ done by India's Central TB Division, Imperial College in London and the Bill & Melinda Gates Foundation ­ looked at sale of anti-TB drugs in the country to estimate India has 2.2 million patients in the private sector alone. The total TB disease burden in India could be almost 3.8 million, said the first study. “Our study shows as chemists don't dispense anti-TB drug without prescription, most anti-TB drugs are given to patients diagnosed (rightly or wrongly) as TB patients,” said the authors.

        Wednesday, 24 August 2016

        Antibiotics may up Type 1 diabetes risk in children

        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 treat many infections in children.

        Short pulses of antibiotics caused non-obese diabetic (NOD) mice -- that are more susceptible to Type 1 diabetes -- to develop the disease more quickly and more often than mice not treated with antibiotics.

        Specifically, male NOD mice exposed to PAT were found to have twice (53 per cent) the incidence of Type 1 diabetes as control NOD mice (26 per cent incidence) that received no antibiotics.

        PAT did not significantly increase disease risk in female mice in one set of experiments, but did so in a second set of tests.

        "This is the first study of its kind suggesting that antibiotic use can alter the microbiota and have lasting effects on immunological and metabolic development, resulting in autoimmunity," said Jessica Dunne, Director at Juvenile Diabetes Research Foundation (JDRF) which is a US-based research organisation.

        As children's exposure to microbe-killing antibiotics has increased in recent decades, the incidence of autoimmune diseases like Type 1 diabetes has more than doubled, said the paper published in the journal Nature Microbiology.

        For the research, the team collected samples of gut bacteria from NOD mice to determine the effects of antibiotics.
        Using genomic and statistical techniques, the team found that three-week-old PAT males had a nearly complete loss in their intestines of certain bacteria shown in past studies to normally train the immune system.

        The diversity of species in PAT-treated microbiomes was lower than in control mice, and the composition of the bacterial communities differed greatly, the researchers concluded.

        Pharmacist day competition by IPA

        National Pharmacy Week(NPW) - 2016

        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

        For more details, please see http://www.ipapharma.org/html/npw_2016.html

        CDSCO to launch online service for grant of NOCs for conducting clinical trials soon

        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 of drugs, medical devices, drugs for personal use, drugs for test & analysis and import of cosmetics in first and second phases. Now in third phase, the online service for grant of NOCs for conducting clinical trials will be launched.

        The organisation has launched an online portal for licensing the import of medical device from March, under SUGAM for the import of drugs. The portal only provided benefit for the grant of registration certificates for import of drugs or import license of drugs and the medical device industry. Now the grant of NOC for conducting clinical trails can also be availed.

        Online application system provides an opportunity for user to apply for the grant through online system. It also provides an option to track the status of application online through an application reference number provided by the system at the time of submitting the application.

        Tuesday, 23 August 2016

        Indian pharma industry needs to create & promote ‘Indian brands’ of medicines, machineries: Union Minister

        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 over the world. For this, government of India has been promoting the concept ‘Make in India’, and is ready to provide support for creating infrastructure facilities, subsidies, tax benefits and other services for setting up business units”, the minister said.

        Rupala said government is ready to solve the problems of the industry for making Indian made brands of medicines better quality. The people of the country should feel proud of Indian made products. All the medicines sold in the domestic market should carry the sticker, ‘Made in India’. The SME pharma units will be given adequate help to create a market for their own products.

        Rupala pointed out that Gujarat has made a brand in pharma, likewise, he wanted, Indian drug manufacturers should strive for making a brand for India.

        Participating in the function, Dr. H G Khoshia, Commissioner of Gujarat FDA, said apart from the production of drugs, 40 per cent of the pharmaceutical machineries are also made in Gujarat and they are sold on a comparatively less price. The manufacturers of Indian pharma products can buy all kinds of machineries with latest technology on 1/3 of their prices in the UK markets.

        The PharmaTech Expo 2016, is the fourth edition in the series and is supported by NSIC, Pharmexcil and FDA Gujarat. Large number of visitors from all over the country are visiting the expo. A total of 152 exhibitors from India and abroad are showcasing their latest technologies and innovations in the event.

        A seminar on ‘GMP for SMEs - Schedule M & Beyond’, was held on August 21 by Pharmexcil and, another seminar on ‘Ayurveda--the Future of Healthcare’, was conducted on the next day. The exhibition will culminate at 5pm on August 23.

        Ramesh Shaw, the chairman of the organising group, KNS Media, said the fifth edition of Pharma Tech will be held in Chandigarh next year.

        NPPA revises ceiling prices of 22 scheduled drugs and retail price of 13 formulations

        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,
        ·         primaquine tablet,
        ·         imatinib mesylate tablet,
        ·         procarbazine capsule,
        ·         tamoxifen tablet,
        ·         misoprostol tablet,
        ·         salbutamol tablet,
        ·         ritonavir tablet,
        ·         primaquine tablet,
        ·         cyclosporine oral liquid and
        ·         efavirenz tablet.

        Name of another 13 formulations are
        ·         amlodipine +metoprolol tablet (Starpress-AM XL 25),
        ·         amlodipine +metoprolol tablet (Amlodac M25),
        ·         glimepiride tablet (Glucoryl 4mg),
        ·         r-Hu erythropoietin (r-HuEPO) injection (Renocrit 4000),
        ·         zoledronic acid infusion,
        ·         doxorubicin HCl pegylated liposomal injection,
        ·         telmisartan+ chlorthalidone tablet,
        ·         metformin HCl SR+ voglibose+ glimepiride tablet, paroxetine hcl+ clonazepam capsule (Clonotril P 25mg),
        ·         phenylephrine HCl+ chlorpheniramine maleate+paracetamol+sodium citrate+ menthol syrup (Sudin Kid +),
        ·         phenylephrine HCl+chlorpheniramine maleate+paracetamol+ sodium citrate+ menthol syrup (Nablok-New).
        Set up in 1997, NPPA is entrusted with the task of fixation/revision of prices of pharma products, enforcement of provisions of DPCO and monitoring of prices of controlled and decontrolled drugs.

        “All the existing manufacturers of scheduled formulations, selling the branded or generic or both the versions of scheduled formulations at a price higher than the ceiling price (plus local taxes as applicable) so fixed and notified by the government, shall revise the prices of all such formulations downward not exceeding the ceiling price specified,” said the drug price regulator.

        NPPA had fixed the ceiling price for 123 medicines in July. Overall, since April of this year, it has put fresh ceiling prices for a total 316 drugs.

        Moreover, NPPA fixed the retail prices of 51 new medicines during the past month, bringing the cumulative figure for 2016 to 2017 to 90. The regulator also identified 118 cases of overcharging.

        Based on the new National List of Essential Medicines (NLEM), the government had on March 14 notified the Drugs (Price Control) Amendment Order, 2016. It has 820 formulations. There were 628 formulations under the DPCO of 2013, notified in the wake of the NLEM of 2011.

        Draft rules & syllabus for the B. Pharm course_PCI announcement

        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 to acquire Medivation

        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 XTANDI® (enzalutamide), an androgen receptor inhibitor that blocks multiple steps in the androgen receptor signaling pathway within the tumor cell. XTANDI is the leading novel hormone therapy in the United States today and generated approximately $2.2 billion in worldwide net sales over the past four quarters, as recorded by Astellas Pharma Inc., with whom Medivation entered an agreement in 2009 to develop XTANDI globally and commercialize jointly in the U.S. Since its approval for advanced metastatic prostate cancer by the U.S. Food and Drug Administration in 2012, XTANDI has treated 64,000 men to date in the U.S. alone. Medivation and Astellas have built a robust development program for XTANDI, including two Phase 3 studies in non-metastatic prostate cancer and another Phase 3 study in hormone-sensitive prostate cancer. It is also being further developed in Phase 2 studies for the potential treatment of advanced breast cancer and hepatocellular carcinoma.

        In addition, Medivation has a promising, wholly-owned, late-stage oncology pipeline, which includes two development-stage oncology assets, talazoparib and pidilizumab. Talazoparib, currently in a Phase 3 study for the treatment of BRCA-mutated breast cancer, has the potential to be a highly potent PARP inhibitor and could be efficacious across several additional tumors. Pidilizumab is an immuno-oncology (IO) asset being developed for diffuse large B-cell lymphoma and other hematologic malignancies and has the potential to be combined with IO therapies in Pfizer’s portfolio.

        “We believe the combination with Pfizer is the right next step in our growth trajectory and is a testament to the passion and dedication by which the Medivation team has delivered on our mission to profoundly transform patients’ lives through medically innovative therapies,” said David Hung, M.D., founder, president and CEO of Medivation. “This compelling transaction will deliver significant and immediate value to our stockholders and provides new opportunities for our employees as part of a larger company. We believe that Pfizer is the ideal partner to extend the reach of our blockbuster XTANDI franchise and take our promising, late-stage assets – talazoparib and pidiluzimab – to their next stages of development so that they can be made available to patients as quickly as possible.”
        “The proposed acquisition of Medivation will build upon Pfizer’s success with our IBRANCE® (palbociclib) launch in HR+/HER2- metastatic breast cancer and with our strong immuno-oncology portfolio, and will transform Pfizer into a leading oncology company,” said Albert Bourla, group president, Pfizer Innovative Health. “IBRANCE and XTANDI are anchor brands in breast and prostate cancer respectively, giving Pfizer leadership in two hormone-driven cancers. Similar to IBRANCE in the breast cancer setting, XTANDI is being explored for its potential to move from metastatic prostate cancer to treat earlier stages of non-metastatic prostate cancer. In addition, Medivation’s portfolio within prostate cancer and across diverse tumors will complement Pfizer’s broad IO portfolio. Finally, Medivation adds commercial scale to better compete with other top tier oncology companies in advance of the potential emergence of Pfizer’s IO pipeline expected in the next few years. Together, we believe Pfizer and Medivation can bring the full force of our combined research and resources to combat two of the most common cancers, as well as speed cures and make accessible breakthrough medicines to patients, redefining life with cancer.”

        Cancer remains the second leading cause of death in the U.S. and a “Top 10” killer worldwide. According to the American Cancer Society, breast cancer and prostate cancer are among the top three cancers by annual incidence in the U.S. There are several parallels between breast and prostate cancer, including the incidence of prostate cancer in the U.S., which is similar to that of breast cancer with approximately 280,000 cases per year.

        Pharma cos, docs fail to warn about drugs' side-effects, patients suffer

        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 India are not communicating safety risks and adverse reactions associated with certain medications through package inserts and neither are the doctors informing patients about the same.

        The problem is on several fronts. “The lax system of approval of drugs in India, profit-oriented pharmaceutical companies who care two hoots (about patients), and doctors who are nearly all-dependent on field force do not convey clearly to the patient the possible side effects of a prescribed drug,” says editor of medical journal MIMS CM Gulhati, who has been championing the cause of safe drugs for decades.

        Awareness of safety risks and side-effects is critical when it comes to children and pregnant women. This is because some antibiotics and painkillers are not recommended for use during pregnancy, while some have been banned for lactating women. Doctors are also advised not to prescribe drugs like antibacterials, acid suppressants, codeine (cold and cough remedies) and anti-diarrhoeals to children below 12 years. Most doctors do not ask female patients if they are pregnant or breastfeeding. Hence, if certain drugs not permitted during these situations are administered, it may lead to serious side-effects in such cases.

        Companies feel communicating safety information to patients is akin to advertising, and hence would be in violation of the Drugs and Magic Remedies Act. But drugs controller general GN Singh told TOI, “It is the companies' responsibility to communicate the side effects and adverse events of medicines to ensure patient safety.”

        TOI contacted several companies with queries on the need to educate patients through “clear and efficient labels”, detailing safety risks and precautions. Most pharma companies did not wish to be quoted on the issue. “Since it's not mandatory to provide package insert or a patient medication guide, individual medicine strips do not carry it. Only certain medicines carry these inserts in a pack of 5 to 10 strips,” an executive with a leading company said.

        “It is important that doctors explain common drug reactions to the patient. Also, patients should read the `contraindications and warnings and precautions' sections carefully,” says Dr Anoop Misra, chairman of Delhi based Fortis-C-DOC. According to him, it is the duty of pharmaceutical companies to update package inserts in the event of a newly described adverse effect -which should be disseminated to both doctors and patients. Domestic companies, however, take refuge in laws which do not make it binding on them to provide a medication guide.

        While Indian pharma companies have adopted several global practices voluntarily, why have they chosen to ignore an important aspect of patient safety? More importantly, why hasn't the law been tightened?