Drugs and Cosmetic Act
With the advent of e-pharmacy, there is a need to amend the Drugs and Cosmetics Act 1940as it does not differentiate between offline and online pharmacies. The Government is seized of the issue and is working towards amending the existing law to develop a framework where the consumers are benefitted. This was stated by Mr. K. B. Aggarwal, Additional Secretary (Food and Drugs), Ministry of Health & Family Welfare, while launching a report at a session on ‘E-pharmacy in India – Last Mile Access of Medicines’, organized by FICCI.
Mr. Aggarwal said that e-pharmacy would allow easy availability of drugs at all hours. However, there were concerns with respect to legitimacy of e-pharmacies, patients’ safety and privacy, misuse of e-pharmacy and adverse effect on retailers’ business.
He said that there was a need to create e-pharmacy guidelines which allow proper tracking and monitoring of sales of drugs, authenticity of online pharmacists and prescriptions, details of patients, thereby helping in reducing drug abuse and counterfeiting. He added that linking a person’s Aadhar number with e-pharmacy would ensure correctness of person seeking medicines.
Mr. Aggarwal said that for ensuring privacy and confidentiality of information, deliberations were taking place and soon the suggestions will be put up for further discussions among the stakeholders. He added that the DCGI was working towards developing its online platform and the system should be stable by the end of December 2016.
Dr. S. Eswara Reddy, Joint Drugs Controller, Central Drugs Standard Control Organization, said that the Government was working towards drafting a new Drugs & Cosmetics Act, 2016 to meet the current regulatory requirements related to safety, efficacy and quality of drugs. For the government, pharmaceuticals was a priority sector, therefore it was critical to ensure that its regulations are strengthened. He added that there should be a standard format of prescriptions.
In his presentation Mr. Jayant Singh, Director, Frost & Sullivan, said that e-pharmacy was one of the technology advancements that is about to create a huge demand in the upcoming days. There was a huge demand for access models that help patients and consumers avail the convenience of medicine delivery without having to leave their homes. With the use of technology and access to inventory of multiple stores at a time, e-pharmacies can aggregate supplies, making otherwise-hard-to-find medicines available to consumers across the country.
Dr. Manisha Shridhar, Regional Adviser, World Health Organization, said that for sale of online drugs, in the EU legitimate online pharmacies will have to carry a logo and India could learn from their processes and create its own logo for e-pharmacy. She added that there was a need to work on Direct to Consumer (DTC) as with emergence of e-pharmacy many issues will emerge that would need to be deliberated upon.
In his presentation on the consumer survey, Mr. Afaq Hussain, Director, BRIEF Market Research, said that 90 per cent of the respondents were willing to buy medicines online as epharmacy brings with the convenience of ordering from mobile applications; all required medicines are available at one store/website; home delivery of medicines; better quality of medicines; better pricing and e-bill for tacking and reimbursement.
In his Special Address Mr. Arvind Gupta, Founder & Head, Digital India Foundation, said that there was a need to look at e-pharmacy sector in a comprehensive manner keeping in view the entire healthcare chain. He added that the Aadhar number should be integrated when a person seeks drugs from e-pharmacy to monitor drug abuse and its misuse. He added that there was a need to standardize labs to create digi lockers where the patients’ records are safely documented for reference by doctors.
Mr. Prashant Tandon, Founder & CEO, 1MG, Core Member, FICCI E-Commerce Committee, said that digital tracking and monitoring will take Digital India forward. The Drugs and Cosmetics Act does not address many concerns, hence incremental steps were required to ensure access to quality medicines at affordable price. He added that e-pharmacy sector needs guidelines to function smoothly.
Dr. A Didar Singh, Secretary General, FICCI, said that there was an urgent need to nurture the e-pharmacy sector with the right set of policy frameworks and guidelines in order to provide the benefits that the sector fosters for the consumers. As one of the key agenda of the Government has been to provide easy, quality and affordable access of health services to the consumers, the evolving concept of e-pharmacy will definitely give an impetus to the health sector of the country
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Drug Development Process
The development steps
First, a scientist or a team comes up with an idea for a new drug to treat a disease or a vaccine to prevent one.
If it’s a drug, they will test the compound against the virus or bacteria in vitro – that is Latin for in glass. They might put the drug into a glass plate in which a virus is growing to see if the drug kills off the bugs.
The next step involves testing the experimental product in animals – in vivo, which is Latin for within the living. These animals ideally develop symptoms similar to what humans experience when they are infected with the bacteria or virus in question. If the drug or vaccine cures or protects susceptible animals, it might do the same for people.
Mice are commonly used as models in the early stages of animal testing, but something that works in mice would generally be tested in another animal species as well. Mice are very different from people and the evidence is more persuasive that a drug or vaccine will work if it is effective in a species more closely related to humans than mice. In influenza research, ferrets are often used. In Ebola research, macaques and other non-human primates are employed.
If the animal experiments are successful, the developers of a drug or vaccine will move to test it in people. That work begins with what is called a Phase I trial. These studies are small, often enrolling just a few dozen people, and they are carried out in healthy volunteers. These studies are designed to answer a couple of key questions: 1) is this experimental product safe for people to take, and is it safe to continue to test it? 2) what is the right dose to use in people? When it comes to the dose, researchers are trying to hit the sweet spot: enough so that the product will be effective, but not too much, to limit the risk of toxicity or harmful side-effects.
Phase I trials cannot tell you if a drug or vaccine is effective or not, because the people don’t have the disease that the drug will target, though they can provide hints. In the Phase I trials for Ebola vaccines, for instance, researchers measured the immune response the vaccines provoked.
If a Phase I trial is successful, researchers move on to a Phase II trial, which involves larger numbers of volunteers–say, between 100 and 300. If a drug is tested, the trial will enroll people who have the disease that it’s targeting; if it’s a vaccine, the volunteers are often people at risk of contracting that disease. For instance, researchers could test a malaria vaccine in an African country where malaria occurs. Generally the volunteers will be divided into two groups and will be randomly selected to get either the experimental product or something else to compare it with. That could be a placebo,* a “dummy” pill or shot that should have no effect. Or if there is a drug already available for a condition, an experimental new drug might be tested against it. This kind of study is called a Randomized Controlled Trial (RCT)*
It may seem odd, and even cruel, to give some patients a placebo–why not give everybody the actual drug? The reason is that by comparing the effects of a drug to that of a placebo, researchers can determine how much effect the drug really has. It is considered the fastest and most reliable way to get an answer about whether the drug or vaccine works. And until it is clear that the product being tested does work, it is generally not considered unethical to withhold it. Once a study reveals that a drug works, however, researchers can no longer ethically compare it to a placebo.
A Phase II trial will start to make it clear whether the drug or vaccine being tested actually works; because more people are involved than in Phase I, it will also tell researchers more about the side-effects. If it appears that the drug or vaccine is effective, the developers will proceed to a Phase III trial, which involves still larger numbers of people. This is the level of study that is meant to answer the question: Does this drug or vaccine really work?
Phase III trials typically enlist thousands of people. For the Ebola vaccine trial in Liberia that kicked off early 2015, for instance, 27,000 people were expected to take part.
If a Phase III trial shows that a drug or vaccine is effective, the company developing the product can apply to a regulatory agency such as the U.S. Food and Drug Administration or the European Medicines Agency for a license to produce the product for sale.