Drugs & Cosmetics Act, 1940: Recommendations for a revamp

 Draft Rules to substitute existing Schedule M to bring in GMP on par with international standards

In my opinion, the Drugs and Cosmetics Act is well-drafted and has been amended from time to time with major changes in 1982 and 2008. Rules have a number of amendments and Good Manufacturing Practices are upgraded by amending Schedule M and Medical Devices Rules 2017.

New Drugs and Clinical Trials Rules 2019 have been incorporated. Draft Rules will substitute existing Schedule M to bring in Good Manufacturing Practices (GMP) on par with international standards. Major industry stakeholders want many changes in the draft rules as it is apprehended that it will require huge investment leading to an increase in prices. Medium and small scale industry is likely to be affected most. It has become a fashion to criticise Acts enacted in the pre-independence era.

There is a need for a revised drug classification system

India has made big strides on the World Bank’s ease of doing business index and Prime Minister Narendra Modi’s vision of minimum government and maximum governance. It is commendable but there is an urgent requirement to remove/amend “obsolete” regulations that have outlived their utility and hamper governance by creating avoidable confusion. There are many sections in the Drugs & Cosmetics Act and Rules 1940 & 1945 which needs to be identified on priority. One of them is the current classification of medicines.

Current classification of medicines in India under the Drugs and Cosmetics Act into Schedule G, H, H1, X is outdated, evolved through patchwork over the years and needs to be thoroughly updated. The primary aim of the scheduling system is to ensure appropriate access to medicines while balancing public health and safety. There is a need for a revised drug classification system that is more comprehensive in coverage and eliminates the overlaps between classes and addresses implementation challenges in the diverse and fragmented ecosystem in India.

Accessibility, affordability and lack of transparency are the major challenges in the sector of sale of medicines. These barriers could be effectively overcome by adopting technology, specifically the internet, into the healthcare system. In addition, it provides tracking and traceability of medicines, abuse prevention, addressing consumption of drugs without prescription, tax loss and value-added services for consumer empowerment in healthcare. Moreover, it will foster entrepreneurship, innovation, attract foreign direct investment and create jobs. These are all key areas of national development.

The CDSCO should enforce all drug-related laws throughout the country

The following areas may be considered before redrafting the Drugs and Cosmetics Act and Rules.

• Enforcement of the act

Present scenario: Partly enforced by the Central Government and partly by State Governments.
Result: Uneven enforcement of the rules by the States. The industry grows in some encouraging States only. Clandestine activities in some States with the connivance of officers affect the entire nation.
Suggestion: The CDSCO should enforce all drug-related laws throughout the country.

• Manufacturing Licensing Policy

Present scenario: Loan licences, third party arrangements, manufacturing and marketing arrangements, lending of trade names etc., are being resorted to.
Result: Actual manufacturer suffers in the sales. Sub-standard, not of standard quality, cheap products, unhygienic preparations flood the market. The government is cheated of taxes by the tricks played by large manufacturers. Helps them in money laundering business and to amass black money.
Suggestions: All such unprincipled practices should be banned. Natural justice should be brought back.

• Cold Chain

Present scenario: Only some reputed firms maintain cold chains in distribution.
Suggestions: Even small scale manufacturers and loan licensees should follow it strictly.

• Competent Technical Staff

Present scenario: All science graduates are eligible to become CTS.
Results: Professional pharmacy graduates are unemployed. Quality cannot be built into drugs.
Suggestion: Only pharmacy graduates registered in the pharmacy council, should become CTS for manufacturing and testing. 18-months experience also should be waived. D.Pharm should be approved for quality control CTS as they are more technical than BScs.

Any change should be phased out over a span of a few years while harmonising ICH framework

While the industry is undergoing a paradigm shift towards quality-driven procedures, it is good to see that the national regulators have decided to reframe the guidance. The key focus for the revision should be on harmonisation of quality practices, GMP/GLP requirements, safety and efficacy that would directly benefit the patient population with high-quality medicines. Focusing on these key areas in the upcoming revisions should bridge the gap between the Indian Drugs and Cosmetics Act 1940 and global regulatory standards (ICH, WHO, US-FDA and other regulatory guidance). However, this shift in practice would have a significant implication on the cost dynamics of the product.

Any change should be phased out over a span of a few years, harmonising the ICH framework first and then going into detailed execution to meet the quality standards of other regulated markets. Pharma manufacturers in the Indian market, supplying product to India should be given time to implement quality into systems in a cost-efficient manner. If implemented overnight there will be significant disruptions. On the commercial side, the government should also consider having different price ranges, ceilings and floors for products depending on the therapeutic area of focus, availability and affordability.

Involve pharmacy academicians across the country in making a new law

The Drugs and Cosmetics Act 1940 is archaic and belongs to the British medieval period. In the present scenario, the Act has to deliver robust and safe regulation to meet present-day needs.

What we need is a strong regulatory framework for infrastructure, access to safe and effective medicines, closely monitored clinical trials, cut down on fixed-dose combinations of drugs and encourage single dosage forms. Due to the advent of newer drug delivery systems and dosage forms, the Act needs a complete relook to meet future regulatory needs of the country. It should be simple and easily implementable in a complex country like ours. This should also suit the future medical devices and drug delivery systems which will soon flood the market in the coming years.

Generic drugs should be encouraged in our country to meet the wider aspirations of our public healthcare system. Incorporate recent WHO norms to meet the needs of our country’s huge population. Make graduation in pharmacy compulsory to run pharmacies as done by our neighbours like Bangladesh and Sri Lanka. Involve pharmacy academicians across the country in making new law.

Future amendments of Drugs and Cosmetics Act should provide statutory powers to the CDSCO. The new law should also help in encouraging new drug discovery in the country. This will save a huge tranche of foreign exchange and ensure the availability of affordable drugs to our populations. It will also help fulfil our Prime Minister’s dream of creating an Atmanirbhar Bharat in manufacturing and dispensing of medicines.

The Act needs to be comprehensive, transparent and simplified

The Government of India through the Drugs and Cosmetics Act has made provisions regarding import, manufacturing, sale and distribution of drugs and cosmetics. Despite several subsequent amendments, the Act needs to be more comprehensive, transparent and simplified looking at the current scenario of the pharma market in India. Some of the key considerations are as below:

• Digital platform to be developed to track prices of drugs sold in the market to ascertain compliance to DPCO norms and submission of pricing made by Industry to increase transparency. This will help reduce price overcharging and litigations.
• Drug serialisation to be done for domestic sales to reduce the spurious drugs, counterfeiting and product diversion.
• Considering India as emerging export hub clear guidelines/approval mechanism to be defined by the Central/State FDA for resale of raw material not used by EOU. This will help bring efficiency and reduce material expiry at EOU.
• Information about the availability of medicine, prices, discounts and generic versions of the said medicine to be made available to all the consumers through a digital platform. For e.g., discounts offered by the manufacturer are not fully passed to consumers by retailers in a standardised form, drugs with the same molecular combinations are ava