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EDITOR'S EMULSION

Pooja Khaitan

Warm Greetings on yet another edition of The Prescription!

Reporting the side effects of a drug could help determine if the medicine should stay or be pulled off shelves. A medicine labelled safe for clinical use after trials could still be found to be dangerous. This data is important for a drug to be termed safe for consumption. Unfortunately, India has been poorly reporting adverse drug reactions in the last few years as Pharmacovigilance existed only on paper back then. Things seem to be improving but there’s still lots to achieve. Read our PSM India Capsules to know the reasons behind India’s poor track record in reporting ADRs.

While the Union government has approved the roll-out of the WHO-recommended new triple-drug therapy (TDT) in four select districts, including one in Maharashtra, to eliminate lymphatic filariasis (LF) from the country, the Commerce Ministry exempts pharma companies from barcoding for exports for six months; read this and more about red band warnings to be appearing on all listed drugs from now on under Drug Laws and Policy Injections.

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Do not hesitate to mail your comments on this edition to help us further improve. We appreciate your support and trust in us and are happy to have you as our loyal reader.
Feedback is what keeps us going. Should you have any query or question, please feel free to get in touch with us. Write to me on pooja@jagograhakjago.com

Stay Healthy. Stay Protected.

Pooja Khaitan

Editor-in-Chief,
The Prescription

DOSE OF THE DAY

“Tech companies have taken a hands-off approach to policing search results for drugs, though they are vigilant about policing pharmaceutical advertising. We have been trained to trust the algorithm, but it doesn’t work for public health and safety, and it leads to dangerous results. This is big criminal business that is endangering patients — and it is coming up on page one of a Google search. And patients believe they are getting good information because Google gets it right so many times.”

Libby Baney
Founder and Executive Director of ASOP
(Alliance for Safe Online Pharmacies)

PSM India Capsules

Dealing with Adverse Drug Reactions

With 10 percent of approx. 3.63 trillion medicines popped worldwide in 2015, India is the world’s third-largest medicine market. It stands to scientific reason that these drugs will have side effects. Yet, in 2013, India reported no more than two percent of globally occurring adverse drug reactions (ADRs), jargon for side effects of medicines, logged in Vigibase, maintained by the Uppsala Monitoring Centre, a World Health Organisation collaborating centre for international drug monitoring.

Drug Laws & Policy Injections

Centre To Roll Out Triple-Drug Therapy To Eliminate FilariaPUNE, 9 MAY 2018: The Union government has approved the roll-out of the WHO-recommended new triple-drug therapy (TDT) in four select districts, including one in Maharashtra, to eliminate lymphatic filariasis (LF) from the country. TDT, which uses Ivermectin, Diethylcarbamazine Citrate (DEC) and Albendazole, will also be rolled out in one district each in Uttar Pradesh, Bihar and Jharkhand.

Commerce Ministry Exempts Pharma Companies From Barcoding For Exports For Six Months Mumbai, 4 May 2018: Taking serious note of glitches in functioning of Drug Authentication and Verification Application (DAVA), the Union commerce ministry has directed the Directorate General of Foreign Trade (DGFT) to put implementation of bar-coding on secondary and tertiary packaging of pharmaceutical consignment for exports in abeyance for six months.

Drug Price Control: Niti Aayog For Exemption If Below-10 Per Cent Fall In RateNew Delhi, 8 May 2018: If a drug molecule has seen a price reduction of less than 10 per cent under the current price “control methodology”, the Central government should exempt it from price control, according to a Niti Aayog proposal, which is currently under discussion. If the proposal is accepted by the Centre, around 40 per cent of the drugs that are currently under price control would go out of it.

Govt May Push For Regulating Manufacture, Sale, Import Of Implantable Medical DevicesNew Delhi, 7 May 2018: The government plans to regulate the sale, manufacture and import of implantable medical devices, following a series of controversies that include hip implants by Johnson and Johnson (J&J) which led to adverse reaction in several patients. The move aims to ensure that medical devices that are implanted in the human body are tested for safety before they reach consumers. The Drug Advisory Technical Board (DTAB) will take up the proposal of putting these devices under the purview of the Drugs and Cosmetics Act at its 16 May meeting, according to two people aware of the matter.

Now Red Band Warnings To Appear On All Listed DrugsPune, 7 May 2018: With growing concerns about the emergence of multi-drug resistant bacteria, because of widespread abuse of antibiotics by patients, who consume them without consultation, and by doctors, who prescribe them even when they are not needed, the union health ministry has stepped in with plans to mandate warnings on packets of prescription drugs. Through a new proposal the ministry is planning to stop the drug abuse menace by make changes to the text printed on medicine strips, especially those that fall under Schedule G, Schedule H, Schedule X and Schedule H1.

MoH Issues Labelling Norms For Schedule H, H1 And X Drugs; To Come Into Effect From Nov 1, 2018Bengaluru, 7 May 2018: The Union health ministry has issued labelling norms for Schedule H, H1 and X drugs. The new labelling rules under the Drugs and Cosmetics (Fifth Amendment) Rules, 2018 will be enforced from November 1, 2018. For norms, under rule 96, in sub-rule (1), of clause (xi), the label of the inner most container will bear a caution or warning. The drugs covered under Schedule G or Schedule H or Schedule H1 or Schedule X, specified in rule 97 will be in legible black coloured font size in a completely red rectangular box.

Pharma Injections

Prabhu Urges Pharma Firms To Do More R&D, Develop New MarketsNew Delhi, 9 May 2018: Indian pharmaceutical companies need to increase R&D investments and develop new markets in order to boost their exports, Commerce Minister Suresh Prabhu said on Tuesday. Inaugurating the international exhibition here of pharma and healthcare (iPHEX), with participants from 130 countries, he also called for finding ways to make healthcare more affordable.

Maha FDA Cancels Licences Of 4 Pharma Companies Over Violation Of NormsPUNE, 7 MAY 2018: The Food and Drug Administration (FDA) has cancelled licences of four pharmaceutical companies in Pune division after they were found violating norms. The four companies were found flouting Good Manufacturing Practices (GMP) norms. Licences of 23 other errant manufacturing companies were also suspended.

Cut Dependence On China For Cancer Drug Import: PIL Chennai, 6 May 2018: Claiming that overwhelming dependence of drugs and raw materials from China, particularly those for cancer treatments, could prove harmful those for the health sector in India, a Chennai-based pharmaceutical company has approached the Madras high court to direct the Centre to provide more preference to indigenous manufacturers in procurement of cancer drugs.

Puducherry MLA Moves High Court Against Pharma Factory Expansion Chennai, 5 May 2018: The Madras High Court on Friday issued notices to various governmental bodies in Puducherry after an MLA filed a PIL opposing the expansion of a pharmaceutical industry. The Division Bench comprising Justice V. Bharathidasan and Justice N. Seshasayee on Thursday issued notices to various authorities of the Government of Puducherry, including the Puducherry Pollution Control Committee, based on the appeal by MLA and NR Congress member Ashok Anand.

India’s Pharma Exports Cross $17 Billion Hyderabad, 5 May 2018: India’s pharmaceutical exports have shown a smart turnaround in the last few months, with Europe and other key markets gaining traction and making up for slowdown in North America, an issue that would be brain-stormed at the forthcoming ‘iPHEX’ annual event of the apex industry body Pharmexcil.

Will China's Tariff Exemption Lead To Increase In India's Pharma Exports? New Delhi, 4 May 2018: Chinese Ambassador to India Luo Zhaohui's recent tweet on his country's decision to remove import duties on 28 medicines, including all cancer drugs, has created flutters in India. The fact that it came within a week of Prime Minister Narendra Modi's two day informal summit with Chinese President Xi Jinping in their country on April 27-28 made it look sweeter.

Drug Dopes

Updated LIST OF NEW DRUGS APPROVED FROM 01-01-2018 TILL DATE BY NEW DRUGS DIVISION, CDSCO, FDA Bhawan, New Delhi List of New Drug Approved by FDA

Delhi: Drugs Worth Rs 10 Crore SeizedNew Delhi, 8 May 2018: The Directorate of Revenue Intelligence (DRI) has seized a significant quantity of prohibited drugs such as Alprazolam and Diazepam, worth Rs 10 crore, from the Foreign Post Office (FPO). Officials said these drugs, which are abused as narcotics, were mostly in the form of tablets/capsules inside small packets. “These controlled drugs, which were mis-declared as herbal/health products, were headed to numerous overseas buyers located in the US, UK, Canada and Australia,” an official said.

Rules To Check TB Non-Reporting By Private Doctors, Druggists To Help Track 'Missing Million': CampaignersNew Delhi, 7 May 2018: The Union Health Ministry’s recent move to criminalise non-reporting of tuberculosis (TB) cases to the government would provide a more realistic picture of the disease’s incidence and prevalence in the country and help track the ‘missing million’-- unregistered or undetected patients, say healthcare professionals and non-profit organisations active in anti-TB campaigns.

Maha FDA Raids Reveal Spurious Abortion Medicines, Kits Being Sold Illegally Pune, 5 May 2018: It has come to light that Satara and adjoining districts have been flooded with the sales of illegal medical termination of pregnancy (MTP) kits and pills. This shocking revelation emerged soon after a recent crackdown by the Food and Drug Administration (FDA), Pune Region against illegal sales of the MTP aides.

Untested Medicines Flooding Market Could Be Injurious To Health New Delhi, 5 May 2018: This might come as a bitter pill to swallow. The nonprescription life-saving drugs you are purchasing from the neighbourhood pharmacy could prove fatal.

SHRC Questions JKMSCL Over Supply Of Substandard Drugs Srinagar, 5 May 2018: Taking note of the reports about sub-standard drugs supplied to the government hospitals, State Human Rights Commission (SHRC) has said that the Jammu and Kashmir Medical Supplies Corporation (JKMSCL) has failed to convince the commission that “how drugs that are found sub-standard are withdrawn from hospital stores and made sure people don’t consume them.”

11 Blood Units Found HIV-Infected In ’17’ LUCKNOW, 4 MAY 2018: In 2017, as many as 11units of blood donated at the community blood bank of King George’s Medical University (KGMU) were found to be infected with human immunodeficiency virus (HIV). In past several years, only three to five units of HIV infected blood units had been timely detected annually.

National Injections

CDSCO Increases WHO GMP Certificate To Three Years For Ease Of Doing Business New Delhi, 8 May 2018: In a move to improve ease of doing business, India is increasing the validity of the World Health Organisation (WHO) Good Manufacturing Practices (GMP) certificate to three years. The certificate was earlier valid for two years, said Drug Controller General of India Eswara Reddy during the 6th annual International Exhibition of Pharma and Healthcare (iPHEX) on Tuesday.

Delhi Govt Likely To Put A Cap On Hospital Profits This WeekNEW DELHI, 6 MAY 2018: The Delhi government is likely to come out with a policy to cap profit margins for hospitals this week. A first for any state, the policy will cover sale of medicines, consumables and devices to patients. The state government had appointed a nine-member committee in December last year to suggest the scope and process of capping prices.

Gujarat FDCA Appoints 90 Medical Device Officers To Implement New MD Rules Mumbai, 7 May 2018: The Gujarat Food and Drug Control Administration (FDCA) has notified 90 medical device officers to implement the new Medical Device (MD) rules in the state.

HC Asks Govt To Set Up Panel To Check Adverse Drug Reactions Mumbai, 30 April 2018: Taking note of the increasing number of adverse drug reaction cases in civic-run hospitals, the Bombay High Court has directed the Maharashtra government to set up a committee to analyse the cause and subsequently come up with a solution.

European and Indian Pharmacopoeias Set To Maximise Competencies Of Each Other For High Quality Medicines Bengaluru, 5 May 2018: The European Pharmacopoeia (EDQM) and the Indian Pharmacopoeia Commission (IPC) are working to cooperate on quality control of medicines. Going by the importance of harmonisation to maximise the competence in the every country’s drug manufacture capability, the European Pharmacopoeia recognised Indian pharma's indispensability to the global market.

Patanjali Is Under The Scanner Once Again For 'Post-Dating' Their Products New Delhi, 1 May 2018: India’s food regulator has ordered an inquiry after viral images purportedly showed boxes of a Patanjali product on sale a month before their stated manufacturing date.

Global Injections

'Black Box' Call For Medical Devices To Detect Errors London, 1 May 2018: Medical devices and computers should have a black box style feature similar to aircraft to investigate whether errors have contributed to patient harm, an IT expert has said.

Nigeria: Customs Impounds Two Container Loads of Tramadol By Chioma Obinna, Godfrey Bivbere and Luminous Jannamike : The Tin-can Island Command of the Nigeria Customs Service, NCS, has impounded two containers loaded with Tramadol Hydrochloride (225 milligrams).

Online pharmacy Canada Drugs fined $34M for importing counterfeit cancer drugs HELENA, Mont. (AP) : An online pharmacy that bills itself as Canada’s largest was fined $34 million Friday for importing counterfeit cancer drugs and other unapproved pharmaceuticals into the United States, a sentence that one advocacy group called too light for such a heinous crime.

Tijuana Resident Sentenced For Smuggling And Selling Counterfeit And Illegal Drugs May 2, 2018: The U.S. Department of Justice (DOJ) announced the sentencing of a Tijuana man who smuggled non U.S. Food and Drug Administration (FDA)-approved pharmaceuticals into the country and sold those along with counterfeit erectile dysfunction drugs to residents in San Diego County. Alejandro Hernandez, 54, will spend 30 months in federal prison and has also been ordered to pay almost $10,000 in restitution. Over the course of what was a long-term undercover investigation, agents purchased the counterfeit and non FDA-approved pharmaceuticals from Hernandez six times.

PSM PILL

Illegal Pill Factory In Stamford Connecticut Was Producing Thousands Of Carfentanil-Laced Fake Percocet Pills

May 10, 2018 : A Westover, Connecticut man is under arrest, and authorities there have uncovered a counterfeit Percocet factory in a barn that was producing enough carfentanil pills to kill half the population of Stamford, according to the Stamford Advocate.

Fentanyl Pill Counterfeiters In Arkansas, California, And North Carolina Busted

May 9, 2018: Reports of counterfeit pills made with fentanyl are coming in on a daily basis. Here is a quick recap of three stories, one from Arkansas, one from North Carolina, and one from California: 5 News Online reported that police arrested Lewis R. Chafin of Fayetteville, Arkansas in April for allegedly manufacturing counterfeit oxycodone pills that contained fentanyl. A search of Chafin’s home turned up the 43 counterfeit oxycodone pills along with an array of other drugs, both legal and illegal.

Frequently Asked Questions

Q. Why are counterfeit drugs so dangerous?
Ans: Counterfeit drugs may contain the wrong amount of active ingredient -- or no active ingredient at all. Poisonous ingredients have been found in counterfeit medicines, as well. The risk to the user is significant.
Typical inactive ingredients added to counterfeit medicines include chalk, gypsum, acetaminophen, flour, talcum powder and sugar. Of course, any ingredient, including other potent pharmaceuticals, or simply chemicals or designer drugs concocted in the illegal lab can be added. And what if the amounts are not exactly calculated? For example,
• the amount of active ingredient is too high
• if the dose is too low, treatment failure can occur
• possibly even death due to excessive or inadequate amounts of a product.
As an example, the World Health Organization (WHO) estimates that 100,000 Africans die each year as the result of fake anti-malarial drugs.

SUBSCRIBER'S SYMPTOM

Medical negligence

Article contributed by pharmacist, Mr. Deepak Barai, Mumbai

'Wrong drug led to cardiac arrest': 2-yr-old's parents accuse B'luru hospital of negligence. The distraught father says that his son can't sit up, crawl or speak anymore. The hospital, however, has refuted all allegations. Geetika Mantri

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Mr. Surinder Chaudhary, Pharma Executive tweets: Dear PSM India, Good initiatives and actions! Wish you more success!

Mrs. Ananya Singh, Academician:The PSM-India group has taken a big step towards rejuvenating the dilapidated healthcare system of our country with all its social patient-consumer friendly activities!!

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