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7.                 The vitreous sample was obtained and sent to the laboratory for microbiology and drug sensitivity.  From the report it is noticed that Klebsiella and Pseudomonas organism (bacteria) grew in the vitreous fluid.  The bacteria are sensitive to Moxifloxacin.  The complainant was explained about the necessity of use of Moxifloxacin to control infection and for relief from pain.  Intravitreal Moxifloxacin injection was given on 22.02.2014.  Meanwhile the drug was found contaminated.  Immediately a complaint was given to the Director General, Drugs Control Administration and police report was given in Crime Branch Police Station at Saifabad at the instance of the parties regarding spurious drug.  It is difficult to detect fake from the original on physical inspection of the vial.  On physical inspection of vial, it is a clear fluid with no visible particulate matter.  The complainant was regularly being followed up.  ON 27.02.2014 Posterior Subtenous Triamcinolone injection was given to the left eye to control intraocular inflammation.  As the complainant was having severe pain with no improvement in vision, the complainant was offered repeat Vitrectomy surgery with silicon oil injection to relieve pain and control of infection.  The complainant and his attendants were explained about poor chances of recovery of vision.  The complainant agreed to undergo Vitrectomy surgery and it was performed on 07.03.2014.  The surgery was performed after obtaining consent from the complainant.  The complainant was also advised to keep good control of diabetes.  But after the adverse event his diabetes was under very poor control which added to the severity of the infection and he was not complained with the medications.  With efficient management the opposite parties were able to control infection in the left eye.  However there was total loss of vision to the left eye.  The complainant was explained about the pros and cons with inherent risks and complications involved in every surgical step and obtained three informed consents for each intervention and was clearly explained about the condition of eye at every stage.  While administering the injections every precaution was taken.  There was informed choice of the complainant for all treatment procedures.  Various treatments including two Vitrectomy surgeries, Intravitreal Moxifloxacin, Posterior Subtenous Triamcinolone Injections, multiple consultations and multiple ultra sound scans were done free of charge.  Medications including eye drops and tablets are given free of cost.  The total cost of managing the adverse event for the complainant was approximately rupees two lakhs. 

 16.                        On the other hand the opposite parties no.1 and 2  contended that  on complete examination the complainant was diagnosed to have both eyes moderate diabetic retinopathy with left eye diabetic mocular edema.  He was explained that the disease is a known complication of long standing diabetes leading to accumulation of fluid in the retina and light sensitive layer at the back of the eye.  He was advised Intra Ocular anti VEGF injections therapy to reduce edema and good control of diabetes.  The complainant was given options of two available anti VEGF drugs i.e., Lucentis and Avastin.     The complainant preferred Avastin and was present on 20.02.2014 for the injection.  The drug was administered to the complainant under the supervision of Dr.Rajarami Reddy in the operation theatre under standard ascetic conditions.  Special consent was taken for injection Avastin before the procedure.  The complainant was clearly explained that he has to report immediately to the hospital in case of any pain, redness or reduced vision.  On the same day seven other patients are administered injection using separate syringes in the operation theater under standard aseptic conditions.    As one of the patients who was administered the drug came to the hospital on the same day i.e., on 20.02.2014 complaining pain, redness and decreased vision, all the patients are asked to report immediately for appraisal.  Even the complainant was enquired about the symptoms of pain, redness and decreased vision.  He confirmed the presence of symptoms.  He was asked to report immediately for evaluation.  The complainant ignored the request and presented on the next day morning.  There is delay in coming to the hospital on the part of the complainant after noticing the symptoms and inspite of timely telephonic call and advice from the doctors of opposite party no.1 to visit them immediately.  The five of the patients attended the hospital immediately after noticing pain, redness and decreased vision and they responded positively for the treatment.  The complainant was present on the next day and he was immediately attended to by team of doctors headed by Dr.Rajarami Reddy, Intraocular infection was noticed and an emergency Vitrectomy surgery was performed.  Before undertaking the surgery the complainant was explained the risks involved in the surgery.  Informed consent for vitrectomy surgery was obtained.  The vitrectomy surgery is the standard care in infections following intraocular injections.   The vitreous sample was obtained and sent to the laboratory for microbiology and drug sensitivity.  From the report it is noticed that Klebsiella and Pseudomonas organism (bacteria) grew in the vitreous fluid.  The bacteria are sensitive to Moxifloxacin.    Intravitreal Moxifloxin injection was given on 22.02.2014.  Meanwhile the drug was found contaminated.  Immediately a complaint was given to the Director General, Drugs Control Administration and police report was given in Crime Branch Police Station at Saifabad at the instance of the parties regarding spurious drug.  It is difficult to detect fake from the original on physical inspection of the vial      As the complainant was having severe pain with no improvement in vision, the complainant was offered repeat Vitrectomy surgery with silicon oil injection to relieve pain and control of infection.   The Vitrectomy surgery   was performed after obtaining consent from the complainant.  The complainant was also advised to keep good control of diabetes.  But after the adverse event his diabetes was under very poor control which added to the severity of the infection and he was not complaint with the medications.  With efficient management the opposite parties were able to control infection in the left eye.  However there was total loss of vision to the left eye.  Various treatments including two Vitrectomy surgeries, Intravitreal Moxifloxacin, Posterior Subtenous Triamcinolone Injections, multiple consultations and multiple ultra sound scans were done free of charge.  Medications including eye drops and tablets are given free of cost.  The total cost of managing the adverse event for the complainant was approximately rupees two lakhs. 

26.               Off‑label use is the use of pharmaceutical drugs for an indication, age group, dosage, or route of administration that is not approved by the regulatory agencies and is not mentioned in the prescribing information for the drug.  A regulatory agency (e.g., Drugs Controller General of India, United States Food and Drug Administration [USFDA]) approves a drug for a particular indication, in a particular dose, dosage formulation and route of administration based on data from clinical trials that have been submitted to and scrutinized by the regulatory agency.   Thus, Avastin is approved for oncology indications only for intravenous use but not to be injected in to the eye.   It is important to understand that off‑label use is not illegal. Off‑label use is considered as legal unless it violates ethical guidelines or other safety regulations.  Avastin is in fact   a single use vial without preservatives.  In the instant the most probable root cause for contamination could be due to an inappropriate intravitreal administration or due to contamination of the vial during the "aliquoting" the product into syringest for its " intravitreal" administration.  Therefore, the opposite parties no.1 and 2 committed gross negligence in administering off-label drug Avastin  on the complainant and 8 others which is contrary to the specifications which were clear on the label.   If for the arguments sake it is to be considered that the off label drug is safe for the use in ophthalmic use, the opposite parties no.1 and 2 ought to have used the said drug as a single use but not by withdrawing the drug into multiple syringes.   Though the complainant has gave his consent for the use of Avastin which is said to be off-label drug yet as the complainant is not having any knowledge about what is off-label drug and also that due to his condition at that time he might have signed the said consent form.  First of all it is the opposite parties no.1 and 2 who should not have used the off label drug for administration for the use of ophthalmic purpose and secondly, the opposite parties no.1 and 2 have stated that as the Lucentis is   very expensive compared to Avastin they have used the Avastin in order to reduce the expenses.  The complainant has stated in the complaint that he first visited Sarojini Devi Eye Hospital for the said treatment and when the doctors at the said hospital asked him to get admitted in the hospital the complainant preferred opposite party no.1 hospital with the belief that private hospital rendered best services and provide best care.  If the intention of the complainant is to join in private hospital means he is ready bear the expenses of the costly medicines and also that the complainant has no where stated that he is a poor person so that he cannot bear the expenses of costly drugs.  It is the opposite parties no.1 and 2 who advised the complainant the said drug which is to be administered only on Thursday of every week so that the opposite parties no.1 and 2 can use the medicine for 8 to 10 patients.      Although some off‑label therapies can be beneficial and even lifesaving for some patients, in many cases, off‑label use can be problematic, especially if there is inadequate data regarding drug safety and effectiveness for the off‑label use.   Off‑label use may be associated with a greater number of side effects, the benefits may outweigh the risks.  The law is clear about the off-label use of drugs. In India it is illegal to use drugs for anything else other than what has been approved of by the DCGI.     

 27.                        The opposite parties no.1 and 2 themselves have admitted that various treatments including two Vitrectomy surgeries, intravitreal Moxifloxacin, Posterior Subtenous Triamcinolone injections, multiple consultations and multiple ultra sound scans were done free of charge.  Further, medications including eye drops and tablets were given free of cost.  The total cost of managing the adverse event for the complainant was approximately rupees two lakhs.  Therefore, it can be said that  the opposite parties no.1 and 2     have committed negligence in administering off-label drug Avastin by injecting in to the left eye of the complainant and also to 8 other patients and in that process as the said drug was contaminated.  Avastin is a single use vial as stated by the opposite party no.3 without preservatives and is approved for oncology indications only.  There is every possibility for causing the adverse events i.e., severe ocular inflations following intravitreal injections etc., was due to usage of off-label drug Avastin.