Amendment in Schedule K Drugs and Cosmetic Act

Amendment in Schedule K Drugs and Cosmetic Act

Dr KK Aggarwal

President HCFI

The government under the drugs and cosmetic rules scheduler K (5.23) provides special provision under the National Health Program to SUPPLY defined drugs under the National Health Program by health care providers ( other than doctors).

I am personally of the opinion

1.     The non MBBS healthcare providers SUPPLY and not PRESCRIBE

2.     Under the National Health Program the treatments are always under supervision and are accountable by the CMO

3.     Treatments are standard protocol based and not intellect based.

4.     All ASHA workers are already giving Injection Gentamycin to a new born suspected to be with sepsis before transfer

5.     All Asha workers are already giving IV Methargin for PPH before transfer

6.     Most ANMs are delivering babies

7.     Most Asha Workers are already giving vaccinations, contraception

8.     All malaria workers are giving anti-malarial drugs

9.     All drugs used in National Health Programs are essential drugs classified in NLEM

10. Under the Essential Commodities act 1955: the government has power to control production, supply, distribution, etc., of essential commodities: 2d: for regulating by licences, permits or otherwise the storage, transport, distribution, disposal, acquisition, use or consumption of , any essential commodity;

What is the original clause:

5. 23: Drugs supplied by:

(i) Multipurpose Workers attached to Primary Health Centres/Sub-Centres,

(ii) (ii) Community Health Volunteers under the Rural Health Scheme and

(iii) Nurses, Auxiliary Nurse, Midwives and Lady Health Visitors attached to Urban Family Welfare Centers/Primary Health Centre/Sub Centres and Anganwadi Workers.]    

The provision of Chapter IV of the Act and the Rules thereunder which require them to be covered by a sale licence are excluded, provided the drugs are supplied under the Health or Family Welfare Programme of the Central or State Gov

What is the Amendment

It now will include “ in Health & Wellness Centres in rural and urban areas, Community Health Volunteers such as Accredited Social Health Activists (ASHAs) under the National Health Mission” before Anganwadi Workers in 23 III

They have only added the word Wellness centers which are equivalent to primary health centers and clarified defined the term ASHA workers

Nutraceutical or a drug

Nutraceutical or a drug

Dr KK Aggarwal

President CMAAO and HCFI

Experts from Central Drugs food Standard Control Organisation (CDSCO) and the Food Safety and Standards Authority of India (FSSAI) are debating how to decide a product as a drug or food. Most companies like to launch a food supplement to escape the price control.

The blurred line between drug and supplements surfaced in 2009 when the drug price regulator National Pharmaceutical Pricing Authority (NPPA) said that pharma firms are marketing drugs as food supplements to escape the price control.

The joint expert committee of CDSCO and FSSAI formed is meant to ascertain whether the products and ingredients marketed are labelled on the basis of their intended effects on the human body and further to be classified as drugs, vitamins or food.

Submissions be experts say that vitamins need to be allowed

both in health and nutritional supplements if they are within the recommended dietary allowance (RDA) stipulated by Indian Council of Medical Research (ICMR).

It further elaborates that the issue is more of recognizing RDA as the basis and not the ceiling in daily intakes of nutrients.

The submission recommends that vitamins should be allowed both in food as well as drug, depending on the dosages  employed. [Pharmabitz]

FDA approved vs FDA cleared

Dr KK Aggarwal

(CNET Excerpts): The FDA (DCGI and FSSAI) is responsible for telling us which foods, drugs and medical devices are safe for us to use.

There is a big distinction between a drug or medical device that has been FDA approved and those that are FDA cleared. It's important to understand the difference.

What does the FDA regulate?

·         Prescription drugs for humans and animals

·         Over-the-counter drugs

·         Biologics (e.g. vaccines, blood products, biotechnology products and gene therapy)

·         Dietary supplements (not all are subject to FDA regulation)

·         Medical devices (everything from tongue depressors to pacemakers)

·         Surgical implants

·         Food additives

·         Cosmetics

·         Products that give off radiation (e.g. X-rays, microwave ovens)

·         Nicotine replacement therapy  (NRT) products

·         Infant formula

What does 'FDA approved' mean?

"FDA approved" means that the agency has determined that the "benefits of the product outweigh the known risks for the intended use."

Manufacturers must submit results of clinical testing in order to get approval.

When deciding to approve a product or drug, the FDA has to decide if the benefits outweigh the risks. The FDA is usually inclined to approve a product that has a higher risk if the potential benefit is significant -- like an artificial heart valve that can save someone's life.

What products need to be FDA approved?

FDA approval is usually mandatory to market or sell products that might have a significant risk of injury or illness, but can also benefit your health -- such as prescription medications, over-the-counter medications, vaccines and Class III medical devices.

The FDA categorizes medical devices into Class III, Class II and Class I. Complex medical devices that are implanted in your body, are life-sustaining, or have the potential to cause significant injury or illness in the body are in Class III. Those include implanted pacemakers, replacement heart valves and even breast implants.

Lower-risk devices and products used outside of the body, like condoms, motorized wheelchairs and bandages, fall into Class II and Class I. For reference, Apple's ECG app for the Apple Watch is in Class II.

What does 'FDA cleared' mean?

Class II and Class I medical devices are usually "cleared" by the FDA, which means the manufacturer can demonstrate that their product is "substantially equivalent to another (similar) legally marketed device" that already has FDA clearance or approval. Those already-cleared products are called a predicate.

Once the FDA declares that a new medical device is substantially equivalent to a predicate, it is "cleared," and can be marketed and sold in the US.

The system isn't perfect

The problem with the FDA's approval system is that often companies get their product cleared by using older predicates that were recalled for safety reasons.

FDA does not develop any of the products it evaluates for approval. Nor does it conduct its own testing -- instead, it reviews the results of independent lab and clinical testing to determine if the product, drug or food additive is safe and as effective as it claims to be.

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA

Hips Don’t Lie

Reproduced from http://www.indialegallive.com/health/hips-dont-lie-65357, published May 12, 2019

J&J has been told to pay Rs 25 lakh to each patient who underwent surgery due to its faulty implants. Is this enough and how are compensations calculated?

By Dr KK Aggarwal

The Delhi High Court recently directed pharma major Johnson and Johnson (J&J) to make an interim payment of Rs 25 lakh each to four patients who had undergone revision surgeries after receiving faulty hip implants of the company. The direction was issued “without prejudice to the rights and contention of the parties” in the matter. Justice Vibhu Bakhru said the interim payment should be made before May 29, the next date of hearing. The interim order came after J&J volunteered to pay Rs 25 lakh as compensation to the affected patients.

How do we decide compensation in India in cases of clinical trials? Rule 122 DAB of the Drugs and Cosmetics Rules lays down the procedure. The licensing authority, the Drug Controller General of India (DCGI), is the primary body for the causal assessment of injury/death and compensation amount to be paid to a trial participant. In case of occurrence of a serious adverse event, the Expert Committee communicates its recommendation about causality and quantum of compensation to the licensing authority, which then passes the final order.

The sponsor needs to compensate the participant as per the order of the licensing authority. In case of failure to comply, the licensing authority can take necessary action as per the rule, including suspension or cancellation of the clinical trial and/or restricting the sponsor, including his representative(s), from conducting further clinical trials in India.

The compensation will depend on risk factors such as seriousness and severity of the disease, presence of co-morbidity and duration of disease at the time of enrolment in the clinical trial. It would not depend only on the age and annual income of the participant, as in the case of the Motor Vehicles Act and medical negligence cases.

In cases of hip implants, most people will have co-morbid osteoporosis, age-related heart disease or hypertension and in many cases, limited remaining life span.

In cases of medical negligence, the current formula decided in Dr Balram Prasad vs Dr Kunal Saha & Others is as follows: “70 – (age of patient at death/ injury) x annual income + 30% inflation – 1/3rd as personal expenses”. Example: Suppose there is a 60-year-old patient (average age for hip transplant) with Rs 1 lakh income per month, then the compensation payable would be calculated as: 70 – 60 x Rs 12 lakh + 30% – 1/3 = approximately Rs 75 lakh. The compensation will change based on the age and annual income of the patient.

The age and income-based compensation is discriminatory in nature and is being opposed by the Indian Medical Association. The formula of DCGI in clinical trials is the current formula as it is based on the seriousness of the disease and not the subject’s income or age.

ABOUT HIP FRACTURES

A hip fracture can cause life-threatening complications. People over the age of 65 are most at risk because the bones weaken and the risk of tripping and falling increases with age. A whopping 95 percent of hip fractures are caused by falls. These can also lead to earlier mortality. As per the Centre for Disease Control and Prevention, a large proportion of fall deaths are due to complications following a hip fracture. In-hospital mortality rates for hip fractures range from approximately 1 to 10 percent, depending on the location and patient characteristics. The rates are typically higher in men. A year’s mortality rates have ranged from 12 to 37 percent. Approximately half the patients are unable to regain their ability to live independently.

In hip fracture implants, metal-on-metal (MOM) wear is associated with numerous complications. These include early implant failure due to accelerated wear, adverse local tissue reactions and metal hypersensitivity reactions. Adverse local tissue reaction can lead to increased joint fluid in and around the joint and thickened synovium or local tissue necrosis which can be extensive and devastating. In asymptomatic patients (those without hip pain, swelling or dysfunction), only annual orthopaedic follow-up is needed. In patients who develop symptoms suggestive of hip dysfunction, such as pain, swelling or gait abnormality, intervention is needed. If surgical revision is not deemed necessary in such patients, evaluation has to be repeated every six months. So, not all of them will need revision surgeries.

The compensation formula should be transparent and based on the sickness of the patient and not on his or her age alone. As per the current formula for clinical trials calculated by the DCGI, the minimum compensation is Rs 2 lakh and the maximum Rs 45 lakh. There has to be capping of the compensation amount. Remember, if J&J had not come forward about the implant deficiency, all cases would have been decided against the hospitals or the doctors.

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA

Syrup furosemide shortage: Will the DCGI Intervene?

Few days back I visited Satya Sai Heart Hospital in Ahmedabad. The hospital is doing a wonderful job of providing free heart surgeries to children. During the visit I came across a genuine issue: shortage of Furoped (syrup furosemide) in the market.

For children with heart failure, Furoped is a life-saving diuretic.

In an order in November 2017, the price of Furoped was reduced by 92% with the MRP coming down from Rs 106 to Rs 10/-. Then in June 2018, the National Pharmaceutical Pricing Authority (NPPA) increased the per unit price of Furoped from 29 p per ml to Rs 2.60 p.

A 30 ml bottle now costs around Rs 78/-.

Before the November price revision which was undertaken by NPPA without access to market data, the monthly sales of the drug were to the tune of approximately Rs 30- 35 lakh. Supplies dwindled to about 40% in the aftermath of that decision.

About two years back, there was a shortage of two drugs in the market, d-penicillamine (DPEN) and penicillin G potassium (Pentid-Abbott).

D-penicillamine is used to treat patients with Wilson’s disease (copper overload) with liver, neurological and psychiatric manifestations. And, patients have to be on this drug lifelong. The Indian Medical Association (IMA) had raised this issue and both drugs were freely available again.

There can be several reasons for drugs running short in supply. These can include manufacturing and quality problems, delays and discontinuations. 

In the United States, manufacturers provide the FDA with most drug shortage information. And, the agency works closely with them to prevent or reduce the impact of shortages.  All current and resolved drug shortages and discontinuations are reported to FDA at drugshortages@fda.hhs.gov, which are then compiled in a Drug Shortages Database.

But, unfortunately no such system exists in India to take care of drug shortages.

Furosemide is included in the National List of Essential Medicines (NLEM). All formulations of the drug (Tablet 40 mg, Oral liquid 10 mg/ml, Injection 10 mg/ ml) are to be available at all levels of healthcare - primary, secondary, tertiary, as per the NLEM. This means that it is under price control and profits are limited.

The continuing shortage of any life-saving or essential drug is a matter of concern.

All pediatric cardiologists, if they find that Furoped is still in shortage, should voice their concern.

All drug shortages can be reported on the platform of Medical Voice for Policy Change.

Read our earlier stories on this issue:

IMA is change maker: Medical voice is heard

http://blogs.kkaggarwal.com/2017/10/ima-is-change-maker-medical-voice-is-heard/

Artamine shortage

http://blogs.kkaggarwal.com/2016/09/artamine-shortage/

An Open letter to the DCGI To The Drugs Controller General of India (DCGI) Central Drugs Standard Control Organization Directorate General of Health Services Ministry of Health & Family Welfare Government of India Dear Sir This is to bring to your kind attention that there is a shortage of Furoped (syrup furosemide), a diuretic drug, in the market. Furoped is a life-saving drug for children with heart failure. All formulations of furosemide (tablet, oral liquid and injection) are included in the National List of Essential Medicines (NLEM) and are to be available at all levels of health care – primary, secondary and tertiary. The continuing shortage of any life-saving or essential drug is a matter of concern. We request you to look into the matter and ensure that the shortage is taken care of and that no similar shortages or of any other drug included in the NLEM occur in the future. Warm Regards Dr KK Aggarwal President Heart Care Foundation of India

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA

Time for DCGI to respond

We in practice are confused about “sartans” (ARBs or angiotensin receptor blockers). Every other day, a preparation is withdrawn from the market.

Now Torrent Pharmaceuticals Limited  is expanding its recall for Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets, USP, to the consumer level due to detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. The Recall is expanded to include an additional 36 lots of Losartan Potassium Tablets USP and 68 lots of Losartan Potassium/Hydrochlorothiazide Tablets, USP.

The impurity detected in the API is N-Methylnitrosobutyric acid (NMBA). Torrent is only recalling lots of losartan-containing products that contain N-Methylnitrosobutyric acid (NMBA) above the acceptable daily intake levels released by the FDA.

The Drugs Controller General of India (DCGI) should act to ensure availability of such information on its website. The safety profile of all internationally debated drugs should be updated to keep up with the latest developments.

Today, most patients come to know of such controversies through Google and they begin to question their doctor.

As doctors we need to talk in “one voice” and that to what the DCGI has conveyed to us. 

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA

Medical devices industry should comply with labeling requirement

The ministry of consumer affair and ministry of finance should ensure compliance of the rules related to labeling requirement in cases of medical devices. The government should also implement printing of maximum retail price on each unit pack of medical devices at the time of import by deputing a port officer for checking each shipment of medical devices. This is already followed by DCGI for the pharmaceuticals whereby the port officer/ADC Port issues the clearance for each shipment of pharmaceutical products to the Customs Officer as per the Drugs & Cosmetics (D&C) Act.

Department of Consumer Affairs through a notification dated June 23, 2017 had made it mandatory for all medical devices including those notified as drugs to have MRP on unit pack and if sold by a hospital to patient then they can’t claim the status of institutional customer. Additionally, country of origin is now mandated to be labeled on the unit pack.

What is the market?

The medical device market in India is Rs. 70,000 crore.  Corporate Hospitals and MNCs have lobbied for 0% import duty in name of affordability and accessibility of medical devices but passing of the reduction of MRP.

Why MRP?

Government needs to regulate the maximum mark up between ex-factory (weighted average price) and the MRP. The ex-factory price is coming down by competition, but retail prices are shooting up due to high margins charged by retailers and corporate hospitals. Companies to push their brands end up in offering high trade margins. The looser is the customer. The device company has no gain.   

Why country of origin on the label?

Many states offer incentives for products of Indian origin.  

Why Institutional status?

Many companies do not write the MRP on the plea that it is only an institutional supply and MRP is not applicable. If it is without MRP even the institutions cannot sell it to the patients.  

Who makes the profits?

The hospitals… they buy at peanuts cost but sell at a very high price on the plea that they have to store the device and make it available 365 x 24 hours. But remember, most do have a three month credit for payment and a policy to return if the device is not used. The trade margin must have a cap and the government has powers.

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA