Executive Summary: WHO defines fixed dose combination (FDC) as ‘a combination of two or more actives in a fixed ratio of doses’. In other words, FDC includes two or more active pharmaceutical ingredients (APIs) combined in a single dosage form, which is manufactured and distributed in fixed doses. WHO has made it clear that, fixed ratio combination products are acceptable only when the dosage of each ingredient meets the requirement of a defined population group and when the combination has a proven advantage over single compounds administered separately in therapeutic effect, safety or compliance. Accordingly, 19th WHO Model List of Essential Medicines, contains only 27 FDCs out of 414 total medicines. On the contrary, Indian pharmaceutical market is flooded with unnecessary, expensive, hazardous, irrational FDCs. Recent ban by MoHFW on 344 FDCs has again brought attention to these irrational formulations in market. The need of a drug policy guiding the rational use of FDC drugs is stressed more than ever. The following policy brief will address the possible actionable policy options for rational use of FDC drugs. These will include legal, regulatory and promotional measures, which will reinforce and expand the efforts of the Government to ensure that, the irrational FDCs are not manufactured, prescribed, sold or used. Context: Ministry of Health and Family Welfare, Government of India banned production, sale and marketing of 344 FDC drugs, with an immediate effect, through
Due to these incidents and many severe cases of drug side effects that had happened in the past including deaths, the current way drugs are developed and approved are unethical. Therefore, reform in FDA’s management as well as the guidelines is necessary to strengthen safety standards and eliminate problems regarding drug development and regulation.
Counterfeits medicines has spread like wildfire across online shops and unauthorized pharmacies. According to the data that given from World Health Organization(WHO), they estimated that 10 to 30 percent fake medications products are now conquered marketing all over the globe. Eventhough, Malaysia that known as a country that have good system of laws also undergo this serious case when there three to five percent from the medicines that are sold in the country are counterfeit medicines. The identical packaging along with the insane price make some people eager to buy it. Instead of buying the original medicines, you get to buy a whole set of the medicine for the same price! But what dangers do thes products come with? Keep reading to find out.
In this country there are numerous concerns about health care economics. Several factors contribute to the increase of health care costs. One area of concern is the impact of managed care on health care finances. Managed care has been around since the early 1970s. The definition of managed care is a set of contractual and management methods implemented to manage the financing and delivery of health care services. Initial implementation of managed care was for health care cost saving (Getzen & Moore, 2007, p. 203, para. 1). Though Managed care initially addressed several health care finance issues, there are still problems with the current
Notwithstanding this, dosage forms or pharmaceutical kits/packages that embody a fixed dosage regime that do not involve “any professional decision-making have been accepted as patentable” (Abbvie, at para. 112]; CIPO).
FOOD DRUG AND COSMETIC ACT 1938, (FD&C ACT) according to this act it is illegal to import prescription drugs which are not FDA approved into USA by individuals or groups. We (FDA) are a federal regulatory body of United States responsible for regulating the use of the unapproved drugs in United States. The FDA has a ban for importing the unapproved drugs from other countries. The United States Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C. section 331) prohibit the shipment of unapproved drugs, which includes the importing drugs from other countries. The importer can be liable for prosecution by the FDA.
In 1970 the government passed two new regulations that has effect on the pharmaceutical industry. “The India Patent Act prohibited
Pure Food and Drugs Act of 1906 focused on product labeling in order to control the quality of imported drugs. This era of chemistry from 1906-1938 was followed by toxicology after several incidences prompted the congress to pass Federal Food, Drug, and Cosmetic Act (FDC) in 1938. One of the major incidences was the death of more than 100 people (mostly children) who took elixir of sulfanilamide adulterated with the toxin diethylene glycol. FDC act mandated the manufacturers to submit safety proofs to the FDA before marketing. It also extended FDA's control over cosmetics and other therapeutics devices, further authorizing factory inspections to ensure compliance.
When people think of prescription, they usually conceive of “one-size-fits-all” approach to drugs or patient treatment. However, with the emergence of a new concept “precision medicine”, medical community is now aiming for tailored treatments to deliver right drug to the right patient at right time.
If pharmaceutical products which be included in designer drugs, are changed, they affect people very different operation. Therefore, designer drugs are divided into law-evading drug.
Over the counter (OTC) medicines are drugs that can be sold without the prescription of a registered medical practitioner. The word OTC has no proper recognition in India, the drugs included in “prescription-only drugs” are considered to be non prescription drugs. Prescription-only drugs are those medicines that are listed in schedules H and X of the drug and cosmetics (ACT) rules 1945. Hence “OTC drugs are the drugs legally allowed to be sold “over the counter” by pharmacists. More than 1, 00,000 over the counter (OTC) products are now sold in drugstores, convenience stores and supermarkets. Over-the-counter drugs are much more widely available than ever before, whether or not government sanctions them. Just by typing “buy Atorvastatin” in search sites in internet
The healthcare industry has grown significantly since the need for healthcare services and medical coverage have been identified. As the market for healthcare continues to grow the need for policies increases as the drives for healthcare changes to increasing access, decreasing costs, and improving quality (Brook, 2018). According to research health policy refers to this goal that needs to be obtained including the decision, planning, and strategy used within the policy. The need to achieve a balance in healthcare policies is achieved through efficient and fair in outlining the expectations (Morone et al., 2009).
Interest group roots fall back on the constitution and the birth of the American version of democracy
Taking into account the above explained, the pharmacokinetics of medicines is very important and above all, we must integrate everything learned. Even in a population of similar age and weight, drug requirements may be different due
The Uniform Code of Pharmaceuticals Marketing Practices, 2014 (“UCPMP Code”) is a voluntary code issued by the Department Of Pharmaceuticals (“the Department”) relating to marketing practices for Indian Pharmaceutical Companies and as well medical devices industry. Although the UCPMP Code was initially implemented for a period of 6 months; however, after being extended by the Department 5 times, the Department vide its notification bearing no. 5/3/2009-PJ-J/PJ-II (Vol.III) dated 30 August 2016 has extended the UCPMP Code, 2014 till further orders.
Medicinal drugs are very important to everyone, to save their lives and make them get better when they are ill, but there is always a risk with any type of drug, even if they do save peoples lives.