The Prescription: 17th October Issue
PSM INDIA Capsules National Injections Drug Laws & Policy Injections Global Injections Pharma Injections PSM PillDRUG DOPES UpComing Events Editor’s Emulsion FAQ Laughter Dose Blog Addict
News Archive

Pooja Khaitan

I take this opportunity in inviting all our readers to PSM India’s 2nd International conference at India’s holy city, Haridwar. Please go through our PSM India capsules in this issue to know more on the event.

With the Indian govt. focusing on improving health infrastructure, patient safety seems to be in priority now. Drug laws and pharma injections of this issue gives you an insight into various measures being adopted by the Govt.of India in safeguarding patient safety.

As aware consumers we must contribute our bit too to this cause. We must realize that this is our health that is in question. There is nothing more important than our well-being. The PRESCRIPTION is a small means by which PSM INDIA contributes in making you aware. Hope our articles keep your interest alive in this cause .

If you have any suggestions, comments or queries, please email me at
You may find our previous issues on our website or in the NEWS ARCHIVE section of every issue of The PRESCRIPTION, in case you’ve missed any of them. You may also look us up on Facebook under Partnership for Safe Medicines India .

"Call PSM India toll free helpline 1800 - 11- 4424, to bring cases of spurious medicines or any kind of adverse drug reaction to the notice of the authorities.
Please visit our website if you wish to learn about us .
To register a complaint kindly visit our consumer redressal website

Happy Reading !
Stay Safe. Stay Healthy !

Pooja Khaitan
Chief Editor , The PRESCRIPTION Partnership for Safe Medicines India.


“Pharmacies are the first point of contact for the unwell consumers and pharmacists have a vital role in Indian healthcare which needs to be recognized by the policy makers”.

Mrs. Manjiri Gharat,
Vice-President and Chairperson,
Indian Pharmaceutical Association-Community Pharmacy Division (IPA CPD)

PSM India Capsules
Announcement and Invitation to Attend
2nd International Conference on “Patient Safety & Access to Quality Healthcare”
Announcement and Invitation to Attend
Partnership for Safe Medicines (PSM) India Initiative along with All India Women Conference (AIWC), India Pharma Forum (IPF) and Leading Global Consumer/Patient Organisations working in India
(Building International Cooperation to Promote Patient Safety)
Supported by Consumer Affairs Ministry, Govt.of India
2nd International Conference on
“Patient Safety & Access to Quality Healthcare”
7th November , 2014: Radisson Blu Hotel, SIDCUL, Haridwar, Uttarakhand, India – Pin Code: 249603


Join the Partnership for Safe Medicines India movement ! – Campaign against spurious medicines

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National Injections
CDSCO to start collection of drug samples in 15 categories for spurious drugs survey Mumbai, October 2014: The Central Drugs Standards Control Organization (CDSCO) will shortly start collection of samples in 15 categories of drugs including antibiotics as a part of a survey on spurious and not-of-standard (NOS) drugs being conducted in collaboration with Indian Statistical Institute and National Sample Survey Organization (NSSO). Read More
DCGI concludes drive to check quality of medicines in Chhattisgarh Mumbai, Oct 2014: A team of drug control officials from the Drug Controller General of India (DCGI) office recently concluded a random sampling of medicines distributed across the state of Chhattisgarh to detect not-of-standard and sub-standard drugs. Read More
Maha FDA goes undercover to crack inter-state abortion pills racketMumbai, Sept 2014: The Directorate of Food and Drugs Administration (FDA) has busted an illegal abortion drug scheme and arrested three people who were engaged in procuring and peddling the pills in Mumbai. Read More
Adverse drug reaction case; BMC admits faultMumbai, Sept 2014: After three separate cases of adverse drug reaction (ADR) last month, one of which claimed a life, BMC has now admitted to not having stored these drugs at the right temperature. Read More
Delhi Medical Council registers FIR against 13 illegal clinicsNEW DELHI, OCT 2014: As part of its efforts to curb quackery in the national capital, the Delhi Medical Council (DMC) has filed FIRs against 13 illegal clinics operating in the city. Read More
Drug Laws & Policy Injections
Govt to set up ADR monitoring centers in all medical colleges by 2015 Mumbai, October 2014: The Union health ministry is in the process of setting up Adverse Drug Reaction Monitoring Centers (AMCs) in over 380 medical colleges across the country. Ghaziabad based Indian Pharmacopoeia Commission (IPC) which is the national coordination center (NCC) for Pharmacovigilance Programme of India (PvPI) will serve as a nodal agency for the AMCs. Read More
Govt urged to launch online registration forum for manufacturing and marketing cos to regulate drug distribution system Chennai, Oct 2014: In a major suggestion that may help regulate the drug distribution system, the Union government has been urged to launch an online registration forum for all drugs manufacturing and marketing companies, both domestic and foreign, which are engaged in the production and marketing of medicines in the country. Read More
Govt bans polyethylene terephthalate for primary packaging of drugs for paediatric & geriatric use Mumbai, October 2014: The Union Health Ministry has banned the use of polyethylene terephthalate (PET) or plastic containers in liquid oral formulations for primary packaging of drug formulations for paediatric use, geriatric use and for use in case of pregnant women and women of reproductive age group. Read More
Health Ministry amends D&C Rules to make labelling mandatory for medical devices Mumbai, Sept 2014: In a significant move to regulate the mostly unregulated medical devices industry in the country, the Union health ministry has amended Rule 109A of the Drugs and Cosmetics Rules (D&C Rules) to make labelling of medical devices mandatory in the country. Read More
Gujarat FDCA warns companies against improper disposal of discarded raw materials Mumbai, October 2014: With a view to counter the threat arising from improper disposal of raw materials, the Gujarat Food & Drugs Control Administration (FDCA) has asked the stakeholders to take precautions while discarding raw materials. Read More
Pharma Injections
Message from Dr Poonam Khetrapal Singh, WHO Regional Director for South-East Asia on the World Heart Day (29 September) New Delhi, September , 2014 : WHO promotes salt reduction as a “best buy’ for governments to prevent and control non-communicable diseases such as heart diseases and stroke, and recommends a daily salt intake of less than five grams per adult or just under a teaspoon. The recommendation is even lower for children, depending on their energy needs.
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Dr. Harsh Vardhan announces insurance scheme; says ministry focused on improving health infrastructure New Delhi, October , 2014 : Union Health Minister Harsh Vardhan announced on Monday a unique health insurance scheme under the umbrella of Universal Health Assurance Mission (UHAM) of the central government, which he claimed will become “world’s largest public health insurance programme.” Read More
Global Injections
Korea updates medicine serialization timelines South Korea has tweaked the implementation timelines for serializing medicines, giving a phased schedule starting on January 1, 2015. Read More
FDA goes its own way with counterfeit detection device The US FDA has developed its own handheld counterfeit medicines detector that can be deployed at a much lower cost compared to commercially-available devices. Read More

FDA Asks All Medical Professionals to “Know Your Source” To Protect Patients from Fake DrugsSeptember, 2014: The FDA has a new flyer campaign that asks doctors, medical office managers, and others responsible for medication purchasing to ensure that they only buy FDA-approved medication. Only state-licensed wholesale distributors of medication can guarantee the safety of medication prescribed to patients.Read More

Drug Dopes
Sagent Pharma recalls three lots of ketorolac tromethamine injection due to incorrect labels Schaumburg, Illinois, Oct 2014: Sagent Pharmaceuticals, a specialty pharmaceutical company focused on developing, manufacturing, sourcing and marketing pharmaceutical products, announced the voluntary nationwide recall of three lots of ketorolac tromethamine injection, USP, 30mg/mL single-dose vials (NDC numbers 25021-701-01 and 25021-701-02) manufactured by Cadila Healthcare Limited and distributed by Sagent. Sagent has initiated this voluntary recall of ketorolac tromethamine injection, USP, 30mg/mL to the user level due to labelling the product with the incorrect expiration date. The labelled expiration date is longer than the known stability of the product. Read More
US FDA approves Regeneron's Eylea injection to treat macular edema following RVO New York, October 2014: Regeneron Pharmaceuticals announced that the US Food and Drug Administration (US FDA) has approved Eylea (aflibercept) injection for the treatment of macular edema following retinal vein occlusion (RVO), which includes macular edema following branch retinal vein occlusion (BRVO) in addition to the previously-approved indication of macular edema following central retinal vein occlusion (CRVO). The recommended dosage of Eylea in patients with macular edema following RVO is 2 milligrams (mg) every month (4 weeks). "RVO is a significant cause of vision impairment in the US, and this expanded indication across all forms of RVO will provide an important new treatment option for retina specialists and their patients," said George D. Yancopoulos, chief scientific officer of Regeneron and president of Regeneron Laboratories. "Regeneron remains committed to studying Eylea for the treatment of multiple VEGF-driven retinal diseases." Read More

FDA Approves Uceris (budesonide) Rectal Foam for Ulcerative Colitis

RALEIGH, N.C., October 2014 : Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that the Food and Drug Administration (FDA) has granted final approval for Uceris (budesonide) rectal foam for the induction of remission in patients with active mild-to-moderate distal ulcerative colitis (UC) extending up to 40cm from the anal verge. The foam is a rectally administered corticosteroid that overcomes treatment limitations associated with currently approved therapies which are often ineffective due to insufficient distribution of active drug to the distal colon. Read More

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The Partnership for Safe Medicines teamed up with The Doctors Company, the country's largest malpractice group, to educate doctors on this key issue at a time when prosecutions of physicians are increasing.


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Frequently Asked Questions Q1. What are ophthalmic preparations?
Answer: Ophthalmic preparations (eye preparations) are sterile, liquid, semi-solid, or solid preparations that may contain one or more active pharmaceutical ingredient(s) intended for application to the eyes (conjunctiva, the conjunctival sac or the eyelids). The different categories of ophthalmic preparations include drops consisting of emulsions, solutions or suspensions, and ointments. Ophthalmic preparations should maintain their integrity throughout their shelf-life when stored at the temperature indicated on the label. Special storage recommendations or limitations are indicated in individual monographs.

Q2. What are the important instructions that should be remembered while administering such preparations?
Answer: The eye is extremely sensitive and is easily irritated if the composition of the ophthalmic preparation is not appropriate. Eye drops come in single use containers and in multiple dose bottles. Multidose eye drops labelling instruction recommends - To be use within one month (30 days) after opening the container which needs to be followed carefully as they are sterile formulations, but as soon as patients open the bottle for first time, the formulation get exposed to external environment and have high chance of contamination. Moreover, inadvertently dropper tips often touch the eyelids or countertops during use and can contaminate the bottle with bacteria. Preservatives are added to a certain quantity to prevent the solution from external and in inadvertent contamination only up to 30 days. So patient should discard any unused eye drop after 30 days.
Therefore a kind note from PSM Desk that next time you use eye drop/ointment, be careful and diligent in following every instructions as eyes are un-doubted the most vital part of our body.

Laughter Dose
Blog Addicts
Suswasthya Foundation tweets "PSM- India is the torch bearer of the noble cause to protect lives of innocent consumers from counterfeit medicines”.
Dr. Swati blogs “ Partnership for safe medicines has shaped a vision to build a nation of counterfeit free medicine”.
Prof. Amitava says “ I am an passionate reader of PSM Newz/The PRESCRIPTION as it forms an awareness on falsified medicines nationally as well as globally”.
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Disclaimer : Our newsletter endeavors to compile patient safety information from various sources . PSM India may not be held responsible for any article published in The Prescription.