Tides of Indian pharma

·      Tides of Indian pharma by Levin Thomas

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NATIONAL PHARMACEUTICAL PRICING AUTHORITY TO BE LIKELY DISBANDED SOON.

Addressing the concerns regarding excessive price control by the authority while obstructing innovation and competitiveness of the pharma sector, the union health ministry may soon disband National Pharmaceutical Pricing authority (NPPA). Under the current system, the moment a drug is placed under the essential list of medicines, it is subjected to price control mechanism.  The powers of the organisation is supposed to be taken by the government itself for setting up of prices of essential medicines. A third party certification and self certification system will also be put in place to be implemented on annual basis. The new system is proposed to be more flexible and price control will be applicable to drugs only when required. These decisions follow a meeting at the PMO.

NO NEED OF POST OPERATIVE ANTIBIOTIC PROPHYLAXIS: WHO

Antibiotics should only be used to prevent infections before and during surgery and not afterwards (post operative antibiotic prophylaxis), as per the new guidelines issued by World Health Organisation.  Noting that surgical site infections threaten millions of lives and contribute to the spread of antibiotic resistance, WHO said in low and middle-income countries, 11 per cent of patients who undergo surgery are infected in the process.

According to WHO, timing of antibiotic prophylaxis is a key issue. Based on the evidence examined, the panel recommends systemic antibiotic prophylaxis (SAP) be administered 2 hours before incision, mainly for major operations like bowel surgery, cesarean section, and joint replacement but not for minor surgeries. Antibiotics can also be used during an operation, if necessary, especially in procedures that last several hours. The choice of antibiotics is up to the physician and depends on the patient and the procedure. But the evidence that the panel examined, did not show that the use of antibiotics after surgery prevents infections. This is a major change in clinical practice.

The global guidelines for the prevention of surgical site infection included a list of 29 concrete recommendations distilled by 20 of the world's leading experts from 26 reviews of the latest evidence. The recommendations were also published in The Lancet Infectious Diseases and are designed to address the increasing burden of healthcare-associated infections on both patients and healthcare systems globally.

No international evidence-based guidelines had previously been available and there are inconsistencies in the interpretation of evidence and recommendations in existing national guidelines. The new WHO guidelines are valid for any country including India and suitable to local adaptations, and take account of the strength of available scientific evidence, the cost and resource implications, and patient values and preferences.  

  

NEW DRUGS RECENTLY APPROVED IN INDIA

Sl.No.	Drugs	Indication
1.	Acotiamide Hydrochloride Bulk & Tablet 100mg	For the treatment of bloating after meals, epigastric bloating and early satiety in functional dyspepsia.
2.	Sacubutril+ Valsartan film coated tablets 50mg/100 mg/200mg	To reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction.
3.	Lurasidone Hydrochloride Bulk & Lurasidone Hydrochloride Tablets 40mg/80mg	For the treatment of Patients with Schizophrenia
4.	Fenticonazole Nitrate Vaginal Capsule 600 mg	For the treatment of vulvovaginal candidiasis
5.	Palbociclib Capsules 75mg/100mg/125 mg	Palbociclib is a kinase inhibitor indicated in combination with Letrozole for the treatment of postmenopausal women with estrogen receptor (ER)-Positive, human epidermal growth factor receptor 2 (HER2)-Negative advanced breast cancer as initial endocrine-based therapy for their metastatic disease.
6.	Midodrine Hydrochloride 2.5 mg Tablet	For the treatment of symptomatic orthostatic hypotension
7	Phospholipids Fraction from Bovine Lung (surfactant) 50 mg/vial	Preventive use in premature neonates with a high risk of respiratory Distress Syndrome

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