Government Implements Rs. 15,000 Crore Production Linked Incentive Scheme For PharmaceuticalsBy Iednewsdesk On Aug 2, 2024 Share

Government Implements Rs. 15,000 Crore Production Linked Incentive Scheme For Pharmaceuticals

By Iednewsdesk On Aug 2, 2024

 Share

The Department of Pharmaceuticals is implementing the Production Linked Incentive (PLI) Scheme for Pharmaceuticals with a total financial outlay of Rs. 15,000 crore and scheme tenure up to FY 2027-28. The scheme provides for financial incentive to 55 selected applicants for manufacturing of identified products under three categories for a period of six years. The product Category 1 covers drugs such as bio-pharmaceuticals, complex generics, gene therapy drugs, complex excipients, orphan drugs etc. Orphan drugs are those drugs which are used for treatment of rare diseases. Under the scheme, total 8 orphan drugs have been approved for manufacturing. The orphan drugs approved under the PLI scheme for Pharmaceuticals are as follows:

S. No. Name of the product Usage

1 Nitisinone Treatment of Hereditary Tyrosinemia Type 1

2 Nusinersen Treatment of Spinal Muscular Atrophy

3 Rufinamide Treatment of Lennox-Gastaut syndrome.

4 Sodium Phenyl Butyrate Treatment of Urea Cycle Disorders

5 Tiopronin Prevention of Cystine Nephrolithiasis

6 Trientine Hydrochloride Treatment of Wilson’s disease

7 Eliglustat Treatment of Gaucher’s disease

8 Cannabidiol Treatment of Dravet-Lennox Gastaut syndrome

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Clinician-Prescription-Pharmacy

Clinician-Prescription-Pharmacy 

Pharmacy is not just a shop between Clinicians & Patient. It is a check-post to verify prescription.

Pharmacy is a Concept,

Pharmacy is a System,

Pharmacy is a Discipline,

Pharmacy is a Support.

Pharmacy is a Safety bridge between Doctor and Patient 

Its a support to both Clinicians and Patients.

When Judicial Orders are having Checks&Balances Why not for Prescription?

Every step and quality of step is important from prescription to consumption in Pharmacotherapy.

Pharmacists job looks very simple to layman but unfortunately to the Indian Clinicians too!

But, Pharmacist has become knowingly a mute spectator due to lack of recognised empowerment.

Efficacy of Pharma products can be ensured only when stored, handled and used after due training.

Efficacy of Pharmacotherapy can be ensured when Pharmacotherapy is Rational wrt to Cost, Formula and Dosage form.

Knowledge of dose and dosage form is equally important in Pharmacotherapy as Diagnosis.

Understanding the patient and making him to understand pharmacy discipline is more important to get optimum benefits of Pharmacotherapy.

There are Micro and Macro issues that needs to be explained, make the patient understand and followup to optimize the benefits.

We need a Pharmacare system where all Pharmaceutical,  technological , clinical and managerial knowledge inputs are complied that ensures well evaluated Pharmacy system.

The prescription domain remains with Physicians/Clinicians/Doctors but Pharmacy management needs Pharmacist's  input.

( Medication Management ???)

This paves the way for Evidence Based Evaluated Documented Pharmacotherapy.

Unfortunately, we don't have competent leaders who can speak effectively to convince the authorities on the needs and benefits of Pharmacists professional service.

CDSCO and Ministry of Health and Family Welfare have taken following regulatory measures to ensure the quality of medicines in the country:-

[8/2, 10:48 PM] +91 98224 77427: CDSCO and Ministry of Health and Family Welfare have taken following regulatory measures to ensure the quality of medicines in the country:-

The Drugs and Cosmetics Act, 1940 was amended under Drugs & Cosmetics (Amendment) Act 2008 to provide stringent penalties for manufacture of spurious and adulterated drugs. Certain offences have also been made cognizable and non-bailable.

States/ UTs have set up special Courts for speedy trial of offences under the Drugs and Cosmetics Act.

The number of sanctioned posts in CDSCO has been significantly increased in last 10 years.

To ensure efficacy of drugs, the Drugs and Cosmetics Rules, 1945 have been amended providing that applicant shall submit the result of bioequivalence study along with the application for grant of manufacturing license of oral dosage form of some drugs.

The Drugs and Cosmetics Rules, 1945 have been amended making it mandatory that before the grant of manufacturing license, the manufacturing establishment is to be inspected jointly by the Drugs Inspectors of the Central Government and the State Government.

The Drugs and Cosmetics Rules, 1945 have been amended, making it mandatory that the applicants shall submit evidence of stability, safety of excipients etc. to the State Licensing Authority before grant of manufacturing license by the Authority.

Central regulator coordinates activities of State Drug Control Organisations and provides expert advice through the Drugs Consultative Committee meetings held with State Drugs Controllers for uniformity in administration of the Drugs and Cosmetics Act.

 

Under the Drug and Cosmetics Act 1940 and rules framed thereunder, the regulatory control over the manufacture and sale of the drugs is exercised through a system of licensing and inspection by the State Licensing Authorities appointed by the State Governments. Licensee is required to comply with the conditions of license including Good manufacturing practices (GMP) as prescribed under Drugs Rules, 1945. State Licensing Authorities are empowered to take action on violation of any conditions of such licenses including prosecution in appropriate Court of Law. As per the Drugs Rules, 1945 the manufacturing premises whether they are MSME or otherwise, are required to comply with the conditions of license including the Good manufacturing practices (GMP) as prescribed under the Schedule M of the Drugs Rules, 1945. Central Government has amended the Drugs Rules 1945 vide G.S.R. 922 (E) dated 28.12.2023 to revise the Schedule M to the said rules related to Good Manufacturing Practices and requirements of premises, plant and equipment for pharmaceutical products under Schedule M. Quality Management System (QMS) has also been prescribed in the revised schedule M.

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The Central Drugs Standard Control Organisation (CDSCO), in collaboration with state drug controllers (SDCs), has undertaken over 300 enforcement actions after carrying out risk-based inspections of 400 drug manufacturing facilities, Chemical and Fertilisers Minister

[8/2, 10:17 PM] +91 98224 77427: The Central Drugs Standard Control Organisation (CDSCO), in collaboration with state drug controllers (SDCs), has undertaken over 300 enforcement actions after carrying out risk-based inspections of 400 drug manufacturing facilities, Chemical and Fertilisers Minister Jagat Prakash Nadda said in the Lok Sabha.

These inspections also included checking many micro, small, and medium enterprises (MSMEs) to ensure compliance with national drug quality regulations

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Bring Out A Link Document - To Bridge Drugs Act & Pharmacy Act.

#IFDS@PCI

#PPR2015 should have been a #LinkDocument. 

PCI missed a great opportunity of bridging Drugs Act & Pharmacy Act by avoiding right resource persons in drafting PPR2015.

Result of Insight & Forethought Deficiency Syndrome@PCI. (IFDS).

POV : Bhagwan PS

The First #Incompatibility - The Indian Ph'cist Encounters

The First #Incompatibility - The Ph'cist Encounters😄

Rx

👉Pharmacy Act - to regulate pharmacy Education and Profession

👉D&C Act -To Regulate making and selling of Drugs.

Comment : Incompatible Prescription

                     as one nullifies the effect   

                     of the other.

Hence, Referred back to prescriber (Government) to review.

POV : Bhagwan PS

Not only doctors, Pharmacists too have a role in ethical dispensing of prescription medicines.

A Welcome Move.

Not only doctors, Pharmacists too have a role in ethical dispensing of prescription medicines.

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Safe and effective use of medicines is a complementary effort.

MCI Code of Medical Ethics ( Indian Medical Council (Professional conduct, Etiquette and Ethics) Regulations, 2002 and subsequent amendments) has some provisions in it that are of relevance to the pharmacists. 

Regulation 5.3 states that physicians should recognize and promote the practice of pharmacy as profession and should seek their cooperation wherever required.

 According to Regulation 3.7.1, a doctor’s prescription should also make clear if he/she has himself or herself dispensed any medicine to the patient.

 Regulation 7.10 states that a registered medical practitioner shall not issue certificates of efficiency in modern medicine to any unqualified or non-medical person but he/she can issue such certificates to dispensers after proper training.

No physician, as per Regulation 6.3, can run an open shop for sale of medicine for dispensing prescriptions prescribed by other doctors or for sale of medical or surgical appliances. Drugs prescribed by a physician or brought from the market for a patient should explicitly state the proprietary formulae as well as generic name of the drug.

Regulation 1.5 stipulates that as far as possible, drugs should be prescribed with generic names. Every doctor should make sure that there is a rational prescription and use of drugs.

 A Pharmacist should be aware that it is improper for a doctor to affix his/her signboard at a pharmacist’s shop. This is as per Regulation 7.13.

Regulation 7.19 does not allow doctors to use touts or agents for procuring patients. So, a pharmacist should not indulge in such activities.

A pharmacist should know that according to Regulation 1.1.3, no person other than a doctor who holds qualification/s that are duly recognized by MCI and is registered with MCI or State Medical Council can practice allopathic medicine. A practitioner of other systems of medicine cannot practice allopathic medicine. A pharmacist cannot practice and prescribe drugs.

Regulation 1.4.1 requires that every prescription should carry the registration number of the prescribing doctor. The pharmacist should check every prescription he comes across while dispensing medicines.

A pharmacist should also know that according to Regulation 1.4.2, doctors can add as suffixes only those degrees/ certificates/diplomas that are recognized by the regulatory bodies or those memberships/honours which confer professional knowledge or recognizes any exemplary qualification/achievements.

Regulation 1.9 requires all doctors to abide by the laws of country that regulate the practice of medicine and also follow the provisions of State Acts like Drugs and Cosmetics Act, 1940; Pharmacy Act, 1948; Narcotic Drugs and Psychotropic substances Act, 1985; Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954. Neither the doctor nor the pharmacist should be a party to helping others evade these laws.

 A pharmacist should check that all the drugs prescribed by a physician are carrying a proprietary formula and clear name. Regulation 6.5 prohibits dispensing of secret remedial agents by doctors whose composition they do not know. This regulation also considers their manufacture or promotion of their use as unethical.

According to Regulation 6.7, practicing euthanasia is regarded as unethical conduct for the doctor. The pharmacist has a responsibility to check that every prescription is ethical.

 As per regulation 7.20, a Physician shall not claim to be specialist unless he has a special qualification in that branch.

As per regulation 7.3 not displaying the registration number accorded to a physician by the State Medical Council or the Medical Council of India in his or her prescriptions violates the provisions of MCI regulation 1.4.2.

As per Regulation 7.8 a registered medical practitioner shall not contravene the provisions of the Drugs and Cosmetics Act and regulations made there under. Accordingly,  Prescribing steroids/ psychotropic drugs when there is no absolute medical indication and or selling Schedule ‘H’ & ‘L’ drugs and poisons to the public except to his patient shall constitute gross professional misconduct on the part of the physician.

Pharmacists and doctors must keep the records of Sch H1 drugs and narcotics drugs