PHARMA LITERATI

Low-cost Chinese active pharmaceutical ingredients (APIs) continue to throng the Indian market through illegal route, posing a health risk to the people. APIs such as erythromycin stearate, used to treat a wide variety of bacterial infections, are being imported by certain Indian drug companies /traders from China without requisite registration certificates and the material is being sold at a very low price in India. A representation in this regard has already been made to Drugs Controller General of India (DCGI) and the matter is being investigated by regulatory authority. Last month, it was brought to the notice of the DCGI that erythromycin stearate of Shanong Sinder Technology, China was being openly sold by Chennai-based drug companies/traders. It is understood that the importers had lacked certificate of product registration of erythromycin stearate in India thus casting suspicion on quality and efficacy of the product. The API was being supplied by the importers i...

In order to develop skill in pharmacopoeial standard setting and pharmacovigilance (PV) of medical products, the Indian Pharmacopoeia Commission (IPC) will conduct a series of workshops under skill development programme on Pharmacopoeial Standards for Pharmaceuticals (PSP) and skill development programme on Pharmacovigilance for Medical Products (PvM) from May 2019 to December 2019. Expected outcomes of such programme is to create a workforce at national and international level to meet challenges in PV, enable and mobilize a large number of healthcare professionals to take up training and acquire requisite skills for employment, capacity building and strengthening of Qualified Person for Pharmacovigilance (QPPv) as per the requirement of the Schedule Y of D&C Act. These skill certification programmes aim to enable and mobilize a large number of young healthcare professionals to take up training and develop skill in pharmacopoeial standard setting and pharmacovigilance ...

Cholesterol-lowering "statin" drugs taken by millions of Britons may not work well enough in about half of those prescribed them, research suggests. UK investigators looked at 165,000 patients on statins and found that for one in two, the drugs had too little effect on bad cholesterol - one of the big risk factors for heart disease. They are not sure why statins appear to help some more than others. Patients should not stop taking the drugs without seeing their doctor. One possible explanation is patients not taking their prescribed drugs or doctors giving them at too low doses, experts suggest. Cardiovascular disease kills about 150,000 people in the UK each year. " Bad" low-density lipoprotein (LDL) cholesterol is a major contributor - it can lead to furring and blockage of blood vessels. Smoking and obesity Cutting down on saturated fat can help lower bad cholesterol, but some people will also need medication. Millions of people in...

Drawing inspiration from the Kerala High Court Order of 23/08/2017 and from similar orders of various other High Courts, the association of government pharmacists in Punjab is gearing up to approach the High Court of Punjab and Haryana seeking a direction to the state government to allow only qualified and registered pharmacists to dispense drugs in the sub-centres. The State Programme Officer (SPO) of the Health & Wellness Centres (HWCs) in Punjab issued a circular last month assigning Community Health Officers in the sub-centres to dispense medicines to the patients visiting there.  Calling the circular as unjust and contrary to the existing drugs and pharmacy acts, Shubham Sharma, president of Association of Government Pharmacists of Punjab (Democratic) has written to the state health minister, health secretary and to the SPO of the HWC urging them to review the matter and ensure presence of pharmacists at the sub-centres. Since no positive response has come...

In order to give retail trade a better professional recognition, the Union health ministry will soon amend Rule 65(15)(b) and Rule 65(15)(c) of Drugs and Cosmetics (D&C) Rules, to replace ‘Chemists & Druggists’ with ‘Pharmacy’. Once the amendment is done, all the medical shops in the country will be called as Pharmacy.  This is also in concurrence with the international practice of calling a medical shop selling medicines by this name and also provide an identity and sense of value to the practicing pharmacists at the outlets.    This matter was deliberated in the 55th Drug Consultative Committee (DCC) meeting held in February 2019 and it was recommended to replace the words ‘Chemists and Druggists’ with ‘Pharmacy’ in Rule 65(15)(b) of the D&C Rules, 1945.  Accordingly, the proposal was placed before the Drug Technical Advisory Board (DTAB) for deliberation. DTAB deliberated the matter and agreed to amend Rule 65(15) of the D&C Rules, 1945...

The Association of the Hospital and Practicing Biochemists and Medical Technologists (AHPBMT) has sought removal of mandatory requirement of a doctor’s advice to undertake medical tests from draft Clinical Establishments (Central Government) Second Amendment Rules, 2019. The draft amendment released by Union health and family welfare ministry last month says in serial no. 1 that “Medical tests should normally be undertaken on the advice of a doctor” . “This is utter violation of the Constitution of India Article 21 “Right to Life and Personal Liberty” when a person is deprived of matters concerning to his/her life and personal liberty by the state or if a citizen is prevented from liberty of choice of healthcare. It violets the “Charter of Patients’ Rights” prepared by the National Human Rights Commission (NHRC), and Consumer Protection Act 1986. Patients with chronic illnesses, hereditary and lifestyle diseases require frequent tests and even healthy person needs checkups...

The Union health ministry will soon amend Schedule-V of the Drugs and Cosmetics (D&C) Rules, 1945 to revise the limit of 'free salicylic acid' content for medicines containing aspirin based on pharmacopoeial standards applied globally. The matter was taken up for deliberation by the Drugs Technical Advisory Board (DTAB) at its meeting held in New Delhi recently, and it was concluded that the limit of free salicylic acid content shall be not more than 3 per cent in all medicines containing aspirin. The current provision under Schedule-V of the D&C Rules, 1945 states that all patent and proprietary medicines containing aspirin shall be subjected to free salicylic acid test and the limit of such acid shall be 0.75 per cent, except in case of soluble type aspirin in which case the limit of such acid shall be 3 per cent. Aspirin and aspirin containing FDCs are widely used formulations and several such single ingredient, formulations and FDCs are covered u...