After releasing the draft amendment to ban the import of cosmetics tested on the animals recently, the union health ministry has now prohibited the testing of cosmetic products and ingredients on animals within the country.
Through a notification, the ministry has amended the Drugs and Cosmetics Rules 1945 to insert a new rule after 148-B and effected the ban on animal testing for cosmetics. “148-C prohibition of testing of cosmetics on animals- No person shall use any animal for testing of cosmetics,” said the gazette notification.
After approval from the Drugs Technical Advisory Board (DTAB), the ministry had issued the draft notification on January 14, amending the D&C Rules and invited the suggestions from the stakeholders within the mandatory period of 45 days.
“Objections and suggestions received from the public on the said rule have been considered by the central government. Now, therefore, in exercise of the powers conferred under section 12 read with section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government after consultation with the DTAB makes the rules further to amend the D&C Rules,” said the final notification.
Welcoming the notification, Humane Society International/India, said its high-profile Be Cruelty-Free campaign had been instrumental in convincing the Drug Controller General and the ministry of health and family welfare to end animal testing for cosmetics.
“We think this is a huge victory for animals in laboratories, the Be Cruelty-Free campaign and the dozens of legislators who wrote to the health ministry regarding this. India has taken a step forward in ethical consumerism and with the notification, will lead the world towards it too,” HSI said in a statement.
Recently the ministry has released the draft rule to ban the import of cosmetics tested on animals abroad. As per the notification, a new rule (135-B) will be inserted under the Drugs and Cosmetic Rules, 1945 to ban the imports.
The Maharashtra Food and Drug Administration (FDA)’s online WHO GMP certificate generation system, introduced by the FDA around two years ago, has now been upgraded through a robust IT backed system to such a level that the FDA is now able to provide the WHO GMP certificate to the exporters in 10 days.
Besides creating an electronic storage of data for easy retrieval at any time, the new online system developed by the FDA ensures avoiding duplication or counterfeiting of the certificates by assigning a software generated unique authorisation code to each certificate. Among the other unique attributes of the system, the SMS delivery system keeps the manufacturers updated when they are offline and authentication of the certificates can be verified by the authorities very easily.
The new system will go a long way in boosting the exports from the state as this new system will help manufacturing units to get WHO GMP certification for exports in 10 days time as compared to three months in the past.
The manual process was time consuming and entailed scrutiny of the application at three levels by the concerned authorities which once approved was sent by post as a Compliance Letter. This system was followed from 2000 to August 14, 2012.
Earlier, joint commissioner (HQ) was designated for signing the various certificates issued under the WHO GMP certificates. Manufacturers from across the state had to come to Mumbai to apply for the certificates and had to submit a sizeable amount of data in the form of papers. The application thus received was cumbersome as it was first received by the drug inspectors at WHO-GMP section and then by the assistant commissioner, WHO- GMP section followed by the final signatures on the certificates by the joint commissioner (HQ).
There are 1703 manufacturing units in the state out of which 247 units are WHO GMP certified. Exports of medicines worth Rs.15,500 crore have been accounted from Maharashtra in the year 2013-14. There are 883 allopathic units, 452 ayurvedic units, 31 homoeopathic units and 337 cosmetic product units across the state.
With a view to further beef up the process of approvals to clinical trials, the health ministry has begun the process of increasing the number of new drug advisory committees (NDACs) from the current 12 to 50.
The Central Drugs Standard Control Organisation (CDSCO) has already in principle finalized the composition of the new NDACs. The members for the new panels have already been contacted and many of them had given consents verbally and through mails. As and when the consents come from other members, the panels would be formally constituted, sources said.
Following the recommendations by the Parliamentary committee on the functioning of the regulatory mechanism and under pressure from the judiciary, the Health Ministry had formed 12 NDACs to advise on matters related to review and regulatory approval of clinical trials and new drugs (except for Investigational New Drugs).
The technical committee and the apex committee on clinical trials, the two high-level panels set up by the ministry, had recommended the increase in the number of NDACs with a view to involve more experts in the process of clearing the clinical trials in a fool-proof manner. However, there were criticism that the NDACs were not functioning properly.
Another concern was the lack of sufficient number of pharmacologists in the panels. It has been decided that the permission for clinical trials should not be given without consultation with the pharmacologists. In case of permissions cleared by NDACs without pharmacologists, the proposals would again be referred to the pharmacologists of other NDACs.
In some of the NDACs, the expert members have retired, some of the members are no more associated with the organisation and some had refused to attend the meetings, citing busy schedules and engagements, thus defeating the very purpose of the NDACs. The practice is that the pharmacologist specified for particular NDACs are only called to offer expert opinion, not full-time attendance at the meetings.
The All India Organization of Chemists and Druggists (AIOCD) and its state affiliate units will soon approach the union health ministry to demand deferment of the implementation of Schedule H1 as it is being misused by quacks in remote parts of the country as there are drawbacks and ambiguities in the Schedule in its present form.
A letter to this effect has already been sent to the Members of Parliament (MPs) recently. According to the trade body, Schedule H1 in its current form is draconian and amounts to a non-bailable offence if not complied with.
Most of the chemists across the country have not been able to follow the newly amended Schedule H1 which has come into effect in the country from March 1, 2014 due to lack of awareness, cumbersome record keeping, lenient regulatory enforcement and the cost to set up a robust electronic system.
Offenders for non-compliance of Schedule H1 may face penalty ranging from FIRs and cancellation of licenses based on the merit of the case. The central government in September 2013 had amended the Drugs and Cosmetics (D&C) Rules to insert Schedule H1 to curb the indiscriminate use of antibiotics and some other vital drugs, by placing 46 antibiotics under this special category.
AIOCD claims to represent over 7 lakh chemists from across the country. The trade body also reasons out that most of the states except Maharashtra have not been able to implement it as it has taken almost three months for the state drug controllers to sensitise the chemists towards its implementation since it was introduced on March 1, 2014. Moreover, physicians from other systems of medicine have been practicing it in most of the states despite their ineligibility which is detrimental to patient safety.
Only a registered medical practitioner from allopathy is eligible to prescribe Schedule H1 drugs. Among other issues, it has also been argued by AIOCD that implementation of Schedule H1 has become a very expensive proposition for the patient in emergency situations when the pharmacist denies Schedule H1 drug to the patient and asks for a fresh prescription from a physician. The patient has to go the extra mile to get the drug prescribed again at a hefty consultancy fees from the physician ranging from Rs.200 to Rs.1000.
Clarity has also been sought on whether computerised bill is an authorised version or the chemist has to adhere to the manual billing system for compliance to Schedule H1. “The purpose of Schedule H1 has not been understood by the public and that only pharmacists have the onus of maintaining the register is ironical. Besides this, due to the shortage of MBBS doctors in many parts of the country, medical store owners will have the leniency to produce fake bills by putting names of doctors on the bill and rake in profits at the cost of patient safety,” said a pharmacist.
Hyderabad is fast gearing up to host the biggest ever Indo-Global healthcare summit from 20-22nd June, 2014. The international summit is expected to focus on innovations and advances in the fields of medical equipments, manufacture of indigenous drugs and use of information technology for expediting research and development in the pharma and healthcare sectors.
Indo-Global summit will be the biggest ever healthcare summit and expo to be held in Hyderabad. Intellectuals of healthcare from across the world are expected to converge on one platform in the city. Speakers, participants and exhibitors from different countries like USA, UK, Italy, Greece, China, Egypt, Turkey, etc are expected to take part in this global summit.
In fact this summit is organised in the backdrop of Indian healthcare industry growing at a rapid pace. It is expected that the healthcare industry will grow from current US$ 70 billion to US$ 145 in 2017 and to US$ 280 billion industry by 2020. The industry recorded a 12 per cent growth during the past 4 years, informed C D Arha, former Secretary Govt. of India and Chairman of Indus Foundation.
According to Dr N Appa Rao, chief coordinator of the summit, with fast changing dynamics in the healthcare sector across the world, it is high time for Indian healthcare to learn and invest more in research and development. Particularly, the medical devices segment in India is lagging far behind compared to the advanced nations. In view of this, the organisers of the summit expect the Indian entrepreneurs in healthcare and pharmaceutical industry to learn and share knowledge with their counterparts from across the world. The summit is expected to witness about 4000 decision makers apart from other dignitaries and visitors. Around 60 scientific sessions will be held wherein speakers from across the world will take part and share knowledge.
Giving details about the summit, S B Anumolu, president of Indus Foundation, New Jersey, USA said, “The event will help professionals, entrepreneurs, industry players, investors and global institutions to collaborate for taking advantage of the latest innovations and advances.”
The summit is expected to focus on important issues such as universal insurance coverage, optimum utilisation of information technology, production of indigenous drugs, medical devices & equipments, promotion of telemedicine & consultancy, and medical tourism.
Dr V M Katoch, secretary department of health research, and Director-General Indian Council of Medical Research New Delhi will be the guest of honour and he will inaugurate the summit. Many distinguished speakers, healthcare professionals, research scholars, scientists and faculty from some of the internationally renowned organisations of the USA, Australia, Italy, Nigeria, Croatia, Turkey, Egypt, Romania, Malaysia, Greece, Sri Lanka, Denmark, UK, Canada, UAE, Korea, and China will participate in the summit.
The two-day summit is jointly organised by the Indus Foundation, Indian Medical Association, Government of Andhra Pradesh and the Federation of AP Chambers of Commerce and Industry (FAPCCI).