Delhi High Court scraps central government's ban on 344 FDC drugs

NEETU CHANDRA SHARMA
The Centre can't prohibit drugs and cosmetics except when they pose risk to consumers, says court
Medicines, such as Vicks Action 500 Extra and Corex cough syrup that had been off chemists' shelves for some time, will now once again become available to the public. Overturning the ban imposed by the Centre on March 10, the Delhi High Court, on Thursday, ensured that 344 fixed dose combination (FDC) medicines can now be sold again.

The overturning of the ban came about when Justice Rajiv Sahai Endlaw allowed 454 petitions moved by various pharmaceutical and healthcare majors, like Pfizer, Glenmark, Procter and Gamble, and Cipla, challenging the government's ban. The petitions claimed the decision had been taken by the Centre without following due procedure prescribed in the Drugs and Cosmetics Act. As a result, the court, had from March 14 onwards, stayed the operation of the Centre's decision.

The order has drawn mixed responses from various sectors. "The Delhi HC decision is really unfortunate. The 344 FDCs that had been banned did not find mention in any standard textbooks of medicine.

All these FDCs were the creation of the drug companies along with strong misleading promotions. The gullible public will buy such medicines which are both a huge economic waste and harmful," said Dr Gopal Dabade, Coordinator, All India Drug Action Network.

The HC on Thursday said that proceedings till issuance of the notification did not suggest there was any grave urgency to ban these drugs. The court also said that the government's power under section 26A of Drugs and Cosmetics Act cannot be exercised in the public interest, except when a drug poses a risk to consumers.

This is what the drug and pharmaceutical companies had contended in court. They argued that the Centre had not properly implemented its powers under section 26A. They also argued that the ban order was passed without considering clinical data and had termed as "absurd" the government's claim that it took the decision to ban FDCs on the ground that safer alternatives were available.
Defending its stand, the Centre had argued that the FDC medicines are new drugs and thus require a licence from Drugs Controller General of India for manufacture and sale. The government also argued that there were no valid licences for making any of the banned FDCs and added it was difficult to implement any action against them at the state level.

The Centre contended the lack of approval for these FDCs was a secondary issue; the primary focus for the government was that these drugs lacked safety and efficacy, and thus a ban was the only answer. It also said that the banned FDCs had no therapeutic justification.

"The drugs banned were irrational combinations though they did not pose any immediate threat to life. In fact, the use of some irrational FDCs can at times be harmful," said a senior official involved in drug regulatory consultation for the government.

He added that though the government was not against FDCs "There are clear advantages of rational FDCs being used for treatment for parkinson's disease, hypertension, HIV/AIDS. It would have been better to have a detailed deliberate consultation with the various stakeholders to promote awareness of such drugs amongst the public rather than promoting irrational drugs," the official said.

Source: PHM

 

Clexane (enoxaparin)

 

 

Clexane injection contains the active ingredient enoxaparin, which is a type of medicine called a low molecular weight heparin. It is used to stop blood clots forming within the blood vessels.

What is Clexane used for?
Treating blood clots in the veins of the leg (deep vein thrombosis).
Treating blood clots in the lungs (pulmonary embolism).
Preventing these types of blood clots (thromboembolic disorders), particularly following general surgery or surgery on the bones (orthopaedic surgery), or in people bedridden due to illness.
Treating blood clots in the coronary arteries in unstable angina and heart attack (myocardial infarction).
Preventing blood from clotting when it is filtered through an 'artificial kidney' (haemodialysis) machine as part of the management of kidney failure.

How does Clexane work?
Clexane injection contains the active ingredient enoxaparin, which is a type of medicine called a low molecular weight heparin. It stops blood clots forming inside the blood vessels.

Blood clots normally only form to stop bleeding that has occurred as a result of injury to the tissues. The clotting process is complicated and begins when blood cells called platelets clump together and produce chemicals that activate the clotting process. The final part of this process involves a substance called thrombin being activated to produce a protein called fibrin. Fibrin binds the platelets together, forming a blood clot. This is the body's natural way of repairing itself.
Sometimes, however, a blood clot can form abnormally within the blood vessels. This is known as a thrombus. It can be dangerous because the clot may detach and travel in the bloodstream, where it becomes known as an embolus. The embolus may eventually get lodged in a blood vessel, thereby blocking the blood supply to a vital organ such as the heart, brain or lungs. This is known as a thromboembolism.

Some people have an increased tendency for blood clots to form within the blood vessels. This is usually due to a disturbance in the blood flow within the blood vessels. For example, in coronary artery disease, fatty deposits (atherosclerosis) on the walls of the coronary arteries can disrupt the blood flow, giving a tendency for platelets to clump together and start off the clotting process. When a clot has formed in a coronary artery this reduces the flow of blood to the heart and causes chest pain (angina). It can also result in a heart attack.

Slow blood flow in the leg and pelvic veins can also result in clots forming in these veins (deep vein thrombosis). These clots can break off and travel to the lungs (pulmonary embolism). Being immobile for long periods of time, for example due to a severe medical condition or following surgery, can increase the risk of these types of blood clot, as can pregnancy, obesity and certain blood disorders.

Enoxaparin can prevent and treat these types of abnormal blood clots. It works by inactivating thrombin in the clotting process described above. This stops the formation of fibrin, the essential component of blood clots.

Important information about Clexane
During treatment with this medicine you may need to have regular blood tests to monitor the numbers of blood cells called platelets in your blood.
Your doctor may also want to monitor the level of potassium in your blood while you are having this medicine, particularly if treatment lasts for longer than seven days.

Clexane should be used with caution in:
People over 80 years of age.
People who are underweight or overweight.
People with decreased kidney function or chronic kidney failure.
People with decreased liver function.
People who have previously developed a reduced platelet count in the blood due to treatment with heparin or low molecular weight heparin (heparin-associated thrombocytopenia).
People with problems stopping bleeding.
People with a history of peptic ulcer.
People who have recently had a stroke caused by a blood clot in the brain (ischaemic stroke).
Severe uncontrolled high blood pressure (hypertension).
Diabetes.
People with diabetes affecting the eyes (diabetic retinopathy).
People who have recently had eye surgery.
People who have recently had surgery on the brain or spinal cord (neurosurgery).
People having spinal or epidural anaesthesia.
People with a high level of potassium in their blood (hyperkalaemia).
People with increased acidity in their blood (metabolic acidosis).

Clexane should not be used in:
People who are allergic to heparin or other low molecular weight heparins.
People with a bacterial infection of the heart valves and the lining surrounding the heart (bacterial endocarditis).

People with active major bleeding.
People with conditions that carry a high risk of uncontrolled bleeding, for example the blood clotting disorder haemophilia, a peptic ulcer, a recent stroke caused by bleeding in the brain (haemorrhagic stroke) or a reduced platelet count in the blood (thrombocytopenia).
This medicine is not recommended for use in children.
This medicine is not recommended for preventing blood clots in people with an artificial heart valve.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.
If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding
Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
This medicine is not licensed for use during pregnancy. However, the medicine does not cross the placenta and so does not enter the baby's bloodstream. It is not known to be harmful if used during pregnancy. Low molecular weight heparins such as this one are often used to prevent and treat blood clots in pregnant women.
However, the medicine is not recommended for preventing blood clots in pregnant women with artificial heart valves, because there is insufficient information regarding its use in this particular case. Seek further medical advice from your
doctor.

This medicine has not been studied in women who are breastfeeding. However, it is unlikely to pass into breast milk and even if it did, it would be inactivated in the gut of the baby. The medicine is not expected to be harmful to a nursing infant if it is used to treat mothers who are breastfeeding. Seek further medical advice from your doctor.

Possible side effects of Clexane
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

Bleeding. It is important to tell your doctor straight away if you notice any signs of bleeding while you are receiving treatment with this medicine, for example nosebleeds, bruising, coughing up or vomiting blood, blood in your urine, or black, tarry or bloodstained stools.

Pain and irritation at the injection site.
Blood clots which form a solid swelling at the injection site (haematoma).
Decrease in the number of platelets in the blood (thrombocytopenia).
Major bleeding (haemorrhage), for example in the abdomen or inside the skull.
Alteration in results of liver function tests.
Raised blood potassium level (hyperkalaemia).
Death of  skin cells (necrosis) at the site of injection.
Blood clots in the spinal cord (intraspinal haematoma) in people also having spinal or epidural anaesthesia.

Osteoporosis (a reduction in bone density leading to bones which may fracture easily) has occurred after long-term treatment with a similar medicine called heparin. Although this has not been observed in people treated with Clexane, it is possible that this could happen with Clexane.

If you think you have experienced a side effect from a medicine or vaccine you should check the patient information leaflet. This lists the known side effects and what to do if you get them. You can also get advice from your doctor, nurse or pharmacist. If they think it's necessary they'll report it for you.

Source: netdoctor

 

 

Delhi High Court scraps central governments ban on 344 FDC drugs

NEETU CHANDRA SHARMA The Centre cant prohibit drugs and cosmetics except when they pose risk to consumers, says court Medicines, such as Vicks Action 500 Extra and Corex cough syrup that had been off chemists shelves for some time, will now once again become available to the public. Overturning the ban imposed by the Centre on March 10, the Delhi High Court, on Thursday, ensured that 344 fixed dose combination (FDC) medicines can now be sold again. The overturning of the ban came about when Justice Rajiv Sahai Endlaw allowed 454 petitions moved by various pharmaceutical and healthcare majors, like Pfizer, Glenmark, Procter and Gamble, and Cipla, challenging the governments ban. The petitions claimed the decision had been taken by the Centre without following due procedure prescribed in the Drugs and Cosmetics Act. As a result, the court, had from March 14 onwards, stayed the operation of the Centres decision. The order has drawn mixed responses from various sectors. The Delhi HC decision is really unfortunate. The 344 FDCs that had been banned did not find mention in any standard textbooks of medicine. All these FDCs were the creation of the drug companies along with strong misleading promotions. The gullible public will buy such medicines which are both a huge economic waste and harmful, said Dr Gopal Dabade, Coordinator, All India Drug Action Network. The HC on Thursday said that proceedings till issuance of the notification did not suggest there was any grave urgency to ban these drugs. The court also said that the governments power under section 26A of Drugs and Cosmetics Act cannot be exercised in the public interest, except when a drug poses a risk to consumers. This is what the drug and pharmaceutical companies had contended in court. They argued that the Centre had not properly implemented its powers under section 26A. They also argued that the ban order was passed without considering clinical data and had termed as absurd the governments claim that it took the decision to ban FDCs on the ground that safer alternatives were available. Defending its stand, the Centre had argued that the FDC medicines are new drugs and thus require a licence from Drugs Controller General of India for manufacture and sale. The government also argued that there were no valid licences for making any of the banned FDCs and added it was difficult to implement any action against them at the state level. The Centre contended the lack of approval for these FDCs was a secondary issue; the primary focus for the government was that these drugs lacked safety and efficacy, and thus a ban was the only answer. It also said that the banned FDCs had no therapeutic justification. The drugs banned were irrational combinations though they did not pose any immediate threat to life. In fact, the use of some irrational FDCs can at times be harmful, said a senior official involved in drug regulatory consultation for the government. He added that though the government was not against FDCs There are clear advantages of rational FDCs being used for treatment for parkinsons disease, hypertension, HIV/AIDS. It would have been better to have a detailed deliberate consultation with the various stakeholders to promote awareness of such drugs amongst the public rather than promoting irrational drugs, the official said. Source: PHM Clexane (enoxaparin) Clexane injection contains the active ingredient enoxaparin, which is a type of medicine called a low molecular weight heparin. It is used to stop blood clots forming within the blood vessels. What is Clexane used for? Treating blood clots in the veins of the leg (deep vein thrombosis). Treating blood clots in the lungs (pulmonary embolism). Preventing these types of blood clots (thromboembolic disorders), particularly following general surgery or surgery on the bones (orthopaedic surgery), or in people bedridden due to illness. Treating blood clots in the coronary arteries in unstable angina and heart attack (myocardial infarction). Preventing blood from clotting when it is filtered through an artificial kidney (haemodialysis) machine as part of the management of kidney failure. How does Clexane work? Clexane injection contains the active ingredient enoxaparin, which is a type of medicine called a low molecular weight heparin. It stops blood clots forming inside the blood vessels. Blood clots normally only form to stop bleeding that has occurred as a result of injury to the tissues. The clotting process is complicated and begins when blood cells called platelets clump together and produce chemicals that activate the clotting process. The final part of this process involves a substance called thrombin being activated to produce a protein called fibrin. Fibrin binds the platelets together, forming a blood clot. This is the bodys natural way of repairing itself. Sometimes, however, a blood clot can form abnormally within the blood vessels. This is known as a thrombus. It can be dangerous because the clot may detach and travel in the bloodstream, where it becomes known as an embolus. The embolus may eventually get lodged in a blood vessel, thereby blocking the blood supply to a vital organ such as the heart, brain or lungs. This is known as a thromboembolism. Some people have an increased tendency for blood clots to form within the blood vessels. This is usually due to a disturbance in the blood flow within the blood vessels. For example, in coronary artery disease, fatty deposits (atherosclerosis) on the walls of the coronary arteries can disrupt the blood flow, giving a tendency for platelets to clump together and start off the clotting process. When a clot has formed in a coronary artery this reduces the flow of blood to the heart and causes chest pain (angina). It can also result in a heart attack. Slow blood flow in the leg and pelvic veins can also result in clots forming in these veins (deep vein thrombosis). These clots can break off and travel to the lungs (pulmonary embolism). Being immobile for long periods of time, for example due to a severe medical condition or following surgery, can increase the risk of these types of blood clot, as can pregnancy, obesity and certain blood disorders. Enoxaparin can prevent and treat these types of abnormal blood clots. It works by inactivating thrombin in the clotting process described above. This stops the formation of fibrin, the essential component of blood clots. Important information about Clexane During treatment with this medicine you may need to have regular blood tests to monitor the numbers of blood cells called platelets in your blood. Your doctor may also want to monitor the level of potassium in your blood while you are having this medicine, particularly if treatment lasts for longer than seven days. Clexane should be used with caution in: People over 80 years of age. People who are underweight or overweight. People with decreased kidney function or chronic kidney failure. People with decreased liver function. People who have previously developed a reduced platelet count in the blood due to treatment with heparin or low molecular weight heparin (heparin-associated thrombocytopenia). People with problems stopping bleeding. People with a history of peptic ulcer. People who have recently had a stroke caused by a blood clot in the brain (ischaemic stroke). Severe uncontrolled high blood pressure (hypertension). Diabetes. People with diabetes affecting the eyes (diabetic retinopathy). People who have recently had eye surgery. People who have recently had surgery on the brain or spinal cord (neurosurgery). People having spinal or epidural anaesthesia. People with a high level of potassium in their blood (hyperkalaemia). People with increased acidity in their blood (metabolic acidosis). Clexane should not be used in: People who are allergic to heparin or other low molecular weight heparins. People with a bacterial infection of the heart valves and the lining surrounding the heart (bacterial endocarditis). People with active major bleeding. People with conditions that carry a high risk of uncontrolled bleeding, for example the blood clotting disorder haemophilia, a peptic ulcer, a recent stroke caused by bleeding in the brain (haemorrhagic stroke) or a reduced platelet count in the blood (thrombocytopenia). This medicine is not recommended for use in children. This medicine is not recommended for preventing blood clots in people with an artificial heart valve. This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy. If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately. Pregnancy and breastfeeding Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine. This medicine is not licensed for use during pregnancy. However, the medicine does not cross the placenta and so does not enter the babys bloodstream. It is not known to be harmful if used during pregnancy. Low molecular weight heparins such as this one are often used to prevent and treat blood clots in pregnant women. However, the medicine is not recommended for preventing blood clots in pregnant women with artificial heart valves, because there is insufficient information regarding its use in this particular case. Seek further medical advice from your doctor. This medicine has not been studied in women who are breastfeeding. However, it is unlikely to pass into breast milk and even if it did, it would be inactivated in the gut of the baby. The medicine is not expected to be harmful to a nursing infant if it is used to treat mothers who are breastfeeding. Seek further medical advice from your doctor. Possible side effects of Clexane Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect. Bleeding. It is important to tell your doctor straight away if you notice any signs of bleeding while you are receiving treatment with this medicine, for example nosebleeds, bruising, coughing up or vomiting blood, blood in your urine, or black, tarry or bloodstained stools. Pain and irritation at the injection site. Blood clots which form a solid swelling at the injection site (haematoma). Decrease in the number of platelets in the blood (thrombocytopenia). Major bleeding (haemorrhage), for example in the abdomen or inside the skull. Alteration in results of liver function tests. Raised blood potassium level (hyperkalaemia). Death of skin cells (necrosis) at the site of injection. Blood clots in the spinal cord (intraspinal haematoma) in people also having spinal or epidural anaesthesia. Osteoporosis (a reduction in bone density leading to bones which may fracture easily) has occurred after long-term treatment with a similar medicine called heparin. Although this has not been observed in people treated with Clexane, it is possible that this could happen with Clexane. If you think you have experienced a side effect from a medicine or vaccine you should check the patient information leaflet. This lists the known side effects and what to do if you get them. You can also get advice from your doctor, nurse or pharmacist. If they think its necessary theyll report it for you. Source: netdoctor